Radiology AI Directory

FDA-cleared profile

Folliscan

Mim Fertility

Semi-automatic ovarian follicle count and size assessment from transvaginal ultrasound, with clinician verification before clinical use.

Ultrasound workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Semi-automatic ovarian follicle count and size assessment from transvaginal ultrasound, with clinician verification before clinical use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Clinicians interpreting transvaginal ovarian ultrasound examinations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Source-backed baseline patient-population label retained.

Workflow role
Follicle segmentation, measurement and counting
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
DICOM 2D+t cine loops or 3D transvaginal ultrasound scans capturing an ovarian sweep.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Follicle contours, two orthogonal diameters and volume, and counts per ovary in size groups below 10 mm, at least 10 but below 17 mm, and at least 17 mm.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Restores the comparison operators missing from the baseline size-bin text.

Limitations
Results must be manually verified in a DICOM viewer before clinical use. The submitted algorithms are fixed; the software does not replace clinician assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K252332
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Pelvis/Ovaries
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Narrows the baseline Abdomen;Pelvis classification to the explicitly described ovarian target.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-04-20
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM image submission and review workflow, with API use dependent on a validated connector and manual verification of results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Web application or API access through a validated connector.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-06

Family FAQ makes hosting/encryption statements, but scoped dated security evidence and exact-US-configuration data-processing terms were not established.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-06

Exact connector/operator training curriculum, competency assessment and costs require confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-06

Contracted post-installation quality monitoring and incident-handling responsibilities were not established.

Web/API workflow

Web application or API through a validated connector, with manual result verification in a DICOM viewer.

exact submission · checked 2026-09-05
Source

Family integration choices

Vendor describes edge-device, EMR and manual-upload routes with browser access.

product family · checked 2026-09-06
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
The FDA summary describes a held-out test set of 138 scans from 64 patients at five clinics, including 45 US scans, with expert-reviewed reference contours and patient-separated development/test data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Development involved 2132 patients at seven centers and 6404 DICOM datasets; those are not the test denominator. No IVF outcome benefit is inferred.

Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

No product-wide sensitivity with a verified exact-release endpoint/threshold is promoted; follicle measurement and count errors are distinct endpoints.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

No product-wide specificity with a verified exact-release endpoint/threshold is promoted.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K252332 held-out follicle measurement and counting validation

  • DesignMulticenter held-out standalone evaluation against expert-reviewed follicle reference contours
  • Population138 transvaginal ultrasound scans from 64 patients at five clinics; 45 scans from the United States
  • Scopeexact submission
  • Tested versionFolliscan configuration submitted in K252332
  • Samplen=64
  • Sites5
  • IndependenceSponsor or vendor study

K252332

Sample size is patients, not scans or follicles. Patient-level split avoids development/test overlap. The summary's volume error/unit presentation is not promoted as a normalized numeric metric.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-06

Reviewed product page offers contact/demo access, not a verified license, connector, edge-device or implementation price.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-06

No applicable IVF/ultrasound payer policy reviewed; no coverage or separate-payment conclusion is made.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-06

Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-06Last searched
19Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored literature-index and trial-registry candidate arrays were empty and screened. This does not establish absence of literature; current vendor page links newer papers/posters that were not fully reviewed or promoted here. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. Folliscan: K252332 clearance and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: purpose, clinicalUse, modality, anatomy, input, output, limitations, deployment, integration, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Folliscan model card (K252332)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: purpose, modality, intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Folliscan product and integration FAQ

    MIM Fertility - Accessed 2026-09-06

    Scope: productFamilyContext, deployment, implementationCapabilities

Research history

  1. K252332 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

Alternatives

Related tools to compare

FDA-cleared K260667

Alturion Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; ophthalmic; urologic organs; and lung
Decision
2026-06-29
Cardiac imagingUltrasound workflow
FDA-cleared K260190

ARTHUR

ROPCA ApS

Supervised automatic ultrasound image acquisition of hand and wrist joints in adults being investigated or monitored for musculoskeletal disease.

Modality
Ultrasound
Anatomy
Hand/Wrist
Decision
2026-06-18
Ultrasound workflow
FDA-cleared K260844

ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

ACUSON Sequoia, Select, Origin, and Origin ICE diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, pediatric, neonatal, cephalic, small-part,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; transesophageal and intracardiac applications
Decision
2026-06-16
Cardiac imagingUltrasound workflow
FDA-cleared K260300

WatchMate Software

Anumana, Inc.

WatchMate Software v1.2.0 processes transesophageal echocardiography data to reconstruct the left atrial appendage and assist preprocedural planning and device sizing during...

Modality
Ultrasound
Anatomy
Heart and left atrial appendage
Decision
2026-06-15
Cardiac imagingUltrasound workflow