ViewHub® S13
by MacroLux Medical Technology Co., Ltd.
ViewHub® S13 is a Class II device made by MacroLux Medical Technology Co., Ltd., cleared under FDA 510(k) K231774 on 11 Jan 2024 and listed in FDA GUDID since 28 Mar 2024 (UDI-DI 06975339626167), 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 | Number06975339626167 | Date28 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231774 | Date11 Jan 2024 | StatusActive |
Official records
- AccessGUDID record 06975339626167
- FDA 510(k) database K231774
Across registries
- FDA 510(k) K231774 decided 11 Jan 2024 Active
- FDA GUDID UDI-DI 06975339626167 listed 28 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K231774
- Listed FDA GUDID 06975339626167
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ViewHub®
- Generic name
- Endoscopic video image processing unit
- Model / reference
- S13
- Primary DI / UDI-DI
- 06975339626167
- FDA product code
- FGB
- GMDN term
- Endoscopic video image processing unit
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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