FDA.reportPublic FDA data

HS50 Diagnostic Ultrasound System

Primary DI
08809725794926
Brand
HS50 Diagnostic Ultrasound System
Company
SAMSUNG MEDISON CO., LTD.
Model
USS-HS5FN4N/US
Device description
V2.03
Published
2021-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210068000HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2021-04-09IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809725794926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809725794926088097257949268809725794926

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687785691
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088061677611725D VIEWERUSO-U0N5B0B/WR2016-09-26
088061677894665D ViewerUSO-U0N5B0K/WR2018-05-26
08800010500840SonoSync+USO-SSPS200/SW2026-08-18
08800290029376CA2-13MUSP-C02DFSA/WW2026-08-18
08800290036169PA2-9SUSP-P029FSA/WW2026-08-18
08800290036237BCC2-13USP-B02DF1A/WW2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemV6 ONE2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemV7 ONE2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemV8 ONE2026-08-18
08800289979132cV4 Diagnostic Ultrasound SystemcV42025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemcV52025-09-03
08806167766030LA3-16ADLA3-16AD2025-09-03
08809944906476LM2-18DLM2-18D2025-09-03
08809944942450miniER7miniER72025-09-03
08800290027266PA2-9SUSP-P029NSA/WR2026-04-03
08800290027419LA2-9SDUSP-LF29NSA/WR2026-04-03
08800290028638CA2-8ADUSP-C028N7B/WW2026-04-03
08800290029390EV2-10AUSP-V02AN1B/WW2026-04-03
08800290029420CV1-8AEUSP-VN18NSC/WW2026-04-03
08800290029512LA3-16ADUSP-L03GN4B/WW2026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18