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HS50 Uss-HS5NL30/Wr

by Samsung Medison Co., Ltd.

HS50 Uss-HS5NL30/Wr is a Class II device made by Samsung Medison Co., Ltd., cleared under FDA 510(k) K170493 on 28 Mar 2017 and listed in FDA GUDID since 24 Aug 2017 (UDI-DI 08806167764883), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170493

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806167764883 UDI-DI Date24 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170493 Date28 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170493 decided 28 Mar 2017 Active
  • FDA GUDID UDI-DI 08806167764883 listed 24 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170493
  2. Listed FDA GUDID 08806167764883

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HS50
Generic name
General-purpose ultrasound imaging system
Model / reference
USS-HS5NL30/WR
Primary DI / UDI-DI
08806167764883
510(k) Number
FDA product code
ITX, IYO, IYN
GMDN term
General-purpose ultrasound imaging system
Device class
Class II
Regulation number
892.1570, 892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose ultrasound imaging system

Cleared under the same submission (K170493)

and 8 more cleared under K170493

Similar devices in this category

Other devices filed under General-purpose ultrasound imaging system.

Other devices from Samsung Medison Co., Ltd.

See all devices from Samsung Medison Co., Ltd. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)