HS50 Uss-HS5NL30/Us
HS50 Uss-HS5NL30/Us 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 08806167764876), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08806167764876 | Date24 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170493 | Date28 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 08806167764876
- FDA 510(k) database K170493
Across registries
- FDA 510(k) K170493 decided 28 Mar 2017 Active
- FDA GUDID UDI-DI 08806167764876 listed 24 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K170493
- Listed FDA GUDID 08806167764876
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HS50
- Generic name
- General-purpose ultrasound imaging system
- Model / reference
- USS-HS5NL30/US
- Primary DI / UDI-DI
- 08806167764876
- 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
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