FDA-cleared K252018

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

HERA Z20 and the labeled Samsung ultrasound systems acquire and analyze diagnostic ultrasound images and body-fluid information across the labeled adult, pediatric, fetal,...

Modality
Ultrasound
Anatomy
Fetal, obstetric, abdominal, gynecologic, intraoperative, pediatric, small-organ, cephalic, cardiac, thoracic, vascular, and urologic anatomy
Decision
2026-01-05
FDA-cleared K250999

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The Samsung V-family diagnostic ultrasound systems support fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, cardiac, thoracic, vascular,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-07-18
FDA-cleared K243702

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The V8/cV8, V7/cV7, and V6/cV6 diagnostic ultrasound systems and probes obtain ultrasound images and analyze body fluids across the labeled fetal, obstetric, abdominal,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-02-12
FDA-cleared K242511

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The Samsung V5, H5, XV5, XH5, V4, H4, XV4, and XH4 diagnostic ultrasound systems are intended for diagnostic ultrasound imaging and fluid analysis of the human body by...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, and urologic anatomy
Decision
2024-12-10
FDA-cleared K242444

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The HERA W10 and HERA W9 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The FDA indication lists fetal and obstetric,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, pediatric, small-organ, musculoskeletal, and urologic anatomy
Decision
2024-11-27
FDA-cleared K241971

HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The HERA Z20, R20, Z30, and R30 systems and transducers are intended for diagnostic ultrasound imaging and analysis of body fluids. The FDA material lists fetal and obstetric,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, thoracic, vascular, cephalic, small-organ, musculoskeletal, and urologic anatomy
Decision
2024-10-11
FDA-cleared K240516

RS85 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The RS85 diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids. The FDA indication lists fetal and obstetric, abdominal, gynecologic,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, and urologic anatomy
Decision
2024-06-12
FDA-cleared K233112

HM70 EVO Diagnostic Ultrasound System

Samsung Medison CO., LTD.

The HM70 EVO diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids for the listed fetal, obstetric, abdominal, gynecologic, pediatric,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, vascular, lung, and dermatologic anatomy
Decision
2023-12-21
FDA-cleared K231772

V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The V8/H8, V7/H7, and V6/H6 diagnostic ultrasound systems and transducers obtain ultrasound images and analyze body fluids across the labeled fetal, abdominal, gynecologic,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, gynecologic, intraoperative, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, thoracic, transesophageal, and peripheral-vessel anatomy
Decision
2023-10-03
FDA-cleared K230084

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

Samsung Medison CO., LTD.

The HERA W9 and HERA W10 diagnostic ultrasound systems and transducers provide diagnostic ultrasound imaging and fluid analysis across the labeled fetal, abdominal, gynecologic,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, and peripheral-vessel anatomy
Decision
2023-04-21
FDA-cleared K223387

V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The V8 and V7 diagnostic ultrasound systems and probes obtain ultrasound images and analyze body fluids across the labeled fetal, abdominal, gynecologic, intraoperative,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, gynecologic, intraoperative, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, thoracic, transesophageal, and peripheral-vessel anatomy
Decision
2023-02-13
FDA-cleared K221599

HS40 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

HS40 is a general-purpose diagnostic ultrasound system for imaging and analysis of body fluids in fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic organs
Decision
2022-08-22
FDA-cleared K220975

V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

V8 and V7 Diagnostic Ultrasound Systems obtain ultrasound images and analyze body fluids for fetal, obstetric, abdominal, gynecologic, intraoperative, pediatric, small-organ,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2022-06-29
FDA-cleared K220043

HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System

Samsung Medison Co., LTD

HERA W10 and HERA W9 Diagnostic Ultrasound Systems obtain ultrasound images and analyze body fluids for the labeled fetal, obstetric, abdominal, gynecologic, pediatric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic anatomy
Decision
2022-04-05
FDA-cleared K211824

HERA W9, HERA W10 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

HERA W9 and HERA W10 Diagnostic Ultrasound Systems obtain ultrasound images and analyze body fluids across the labeled fetal, obstetric, abdominal, gynecologic, pediatric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2021-09-09
FDA-cleared K210426

HS40 Diagnostic Ultrasound System

Samsung Medison CO., LTD.

HS40 Diagnostic Ultrasound System is a general-purpose diagnostic ultrasound system for imaging and analysis of body fluids across the labeled fetal, abdominal, pelvic,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic anatomy
Decision
2021-05-13