Rapid 5.101
Rapid 5.101 is a radiological PACS-dedicated management software (FDA Class II) made by iSchemaView, Inc., cleared under FDA 510(k) K223396 on 1 Feb 2023 (1 earlier submission) and listed in FDA GUDID since 13 Feb 2024 (UDI-DI B761R51011), 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 | NumberB761R51011 | Date13 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223396 | Date1 Feb 2023 | StatusActive |
Official records
- FDA 510(k) database K223396
- FDA 510(k) database K220499
Across registries
- FDA 510(k) K223396 decided 1 Feb 2023 Active
- FDA GUDID UDI-DI B761R51011 listed 13 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K220499
- Cleared FDA 510(k) K223396
- Listed FDA GUDID B761R51011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 5.101
- Primary DI / UDI-DI
- B761R51011
- FDA product code
- QAS, QIH
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2080, 892.2050
- GUDID distribution status
- In Commercial Distribution
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