Radiology AI Directory

FDA-authorized profile

Rho

16 Bit Inc

Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health assessment.

MSK and bone
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
Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Radiologists and referring clinicians or other physician interpreters.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Radiology and imaging-clinic workflows where standard frontal radiographs are already obtained.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Opportunistic low-BMD risk flagging and referral support after radiograph review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Standard frontal DICOM radiographs plus patient age and sex.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
A positive or negative low-BMD report; positive reports are sent to PACS or a browser, while negative reports do not generate an output.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The De Novo labeling states that Rho cannot rule out low BMD, absence of a report is not a negative result, and it does not replace DXA or clinical assessment. It is limited to the labeled radiograph types and adults aged 50 years and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
DEN230023
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Lumbar spine, thoracic spine, chest, pelvis, knee, hand, and wrist; low bone-mineral-density screening regions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
De Novo
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-04-09
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-authorized
  • 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
The FDA De Novo materials describe DICOM radiograph input, PACS interface, and positive-result delivery to PACS or a browser.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The exact FDA decision material does not establish complete deployment topology, hosting responsibility, availability, upgrade, or service boundaries.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Use by radiologists and referring clinicians or other physician interpreters. Follow the exact labeling, local training, supervision, and escalation requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for DEN230023.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to DEN230023.

exact submission · checked 2026-09-04
Source

Deployment boundary

The exact public deployment boundary is incomplete; confirm hosting, data flow, availability, upgrades, security, service, and downtime locally.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The FDA De Novo materials describe DICOM radiograph input, PACS interface, and positive-result delivery to PACS or a browser.

exact submission · checked 2026-09-04
Source

Clinical acceptance

Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for DEN230023.

exact submission · checked 2026-09-04
Source

Economic evaluation

Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.

product family · checked 2026-09-04
Source

Lifecycle monitoring

Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.

exact submission · checked 2026-09-04
SourceSource

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
DEN230023 FDA decision material reports the exact evidence metrics included below for Rho; values are limited to the stated endpoint, population, and operating point.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

TNI6 low-BMD sensitivity

0.67 proportion

  • EndpointLow-BMD classification sensitivity
  • PopulationTNI6 validation dataset
  • Tested versionRho
Source

TNI6 low-BMD specificity

0.9 proportion

  • EndpointLow-BMD classification specificity
  • PopulationTNI6 validation dataset
  • Tested versionRho
Source

OMN low-BMD sensitivity

0.45 proportion

  • EndpointLow-BMD classification sensitivity
  • PopulationOMN validation dataset
  • Tested versionRho
Source

OAI low-BMD sensitivity

0.36 proportion

  • EndpointLow-BMD classification sensitivity
  • PopulationOAI validation dataset
  • Tested versionRho
Source

DEN230023 FDA evidence package for Rho

  • DesignFDA De Novo clinical validation across three radiographic datasets.
  • PopulationTNI6, OMN, and OAI radiographic validation datasets as tabulated in the FDA De Novo review.
  • Scopeexact submission
  • Tested versionRho
  • Sites6
  • IndependenceSponsor or vendor study

DEN230023

FDA tables include TNI6 n=3,729, OMN n=513, and OAI n=591; the De Novo record is the source anchor and linked FDA review contains detailed tables.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price or commercial contract for the exact submission and version was identified.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product payer coverage or reimbursement determination was identified in reviewed public material.

No product-specific code

No exact-product reimbursement determination identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.

Source

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
No record matched DEN230023 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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
2026-09-04Last searched
27Fields reviewed
11Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

No evidence was promoted. Every record concerns Rho biology or an unrelated clinical intervention and does not identify the 16 Bit Rho device or DEN230023. The current discovery snapshot contains 20 PubMed and 10 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, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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. FDA De Novo record DEN230023: Rho

    U.S. Food and Drug Administration - Published 2024-04-09 - Accessed 2026-09-04

    Scope: identity, submission_linkage, modality, anatomy, clinical_use, intended_users, care_setting, workflow_role, input, output, limitations, evidence

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Rho model card (DEN230023)

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

    Scope: 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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. DEN230023 FDA decision

    Regulatory record

    De Novo

  2. Source-review record updated

    Research record

    human reviewed

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