Rapid 4.9.1
Rapid 4.9.1 is a radiological PACS-dedicated management software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by iSchemaView, Inc., cleared under FDA 510(k) K182130 on 27 Dec 2018 and listed in FDA GUDID since 7 Apr 2020 (UDI-DI B761RAPID49101), 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 | NumberB761RAPID49101 | Date7 Apr 2020 | StatusListed |
| United States | FDA 510(k) | NumberK182130 | Date27 Dec 2018 | StatusActive |
Official records
- FDA 510(k) database K182130
Across registries
- FDA 510(k) K182130 decided 27 Dec 2018 Active
- FDA GUDID UDI-DI B761RAPID49101 listed 7 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K182130
- Listed FDA GUDID B761RAPID49101
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- Withdrawn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 / Ref / Catalog
- 4.9.1, Rapid
- Primary DI / UDI-DI
- B761RAPID49101
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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