DELTAmanager 12
DELTAmanager 12 is a Class II device made by Medimage, Inc., cleared under FDA 510(k) K933321 on 3 Nov 1993 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 00861333000309), active as of 22 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 | Number00861333000309 | Date14 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK933321 | Date3 Nov 1993 | StatusActive |
Official records
- AccessGUDID record 00861333000309
- FDA 510(k) database K933321
Across registries
- FDA 510(k) K933321 decided 3 Nov 1993 Active
- FDA GUDID UDI-DI 00861333000309 listed 14 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K933321
- Listed FDA GUDID 00861333000309
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DELTAmanager
- Generic name
- Multidisciplinary medical image management software
- Model / reference
- 12
- Primary DI / UDI-DI
- 00861333000309
- 510(k) Number
- FDA product code
- KPS
- GMDN term
- Multidisciplinary medical image management software
- Device class
- Class II
- Regulation number
- 892.1200
- GUDID distribution status
- In Commercial Distribution
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