Rapid 4.8.3
Rapid 4.8.3 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 12 Jun 2019 (UDI-DI B761RAPID48302), 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 | NumberB761RAPID48302 | Date12 Jun 2019 | 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 B761RAPID48302 listed 12 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K182130
- Listed FDA GUDID B761RAPID48302
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- Withdrawn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
- 4.8.3, RAPID
- Primary DI / UDI-DI
- B761RAPID48302
- 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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