Rapid 5.102
Rapid 5.102 is a radiological PACS-dedicated management software (FDA Class II) made by iSchemaView, Inc., cleared under FDA 510(k) K230074 on 27 Jul 2023 (2 earlier submissions) and listed in FDA GUDID since 13 Feb 2024 (UDI-DI B761R51020), 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 | NumberB761R51020 | Date13 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230074 | Date27 Jul 2023 | StatusActive |
Official records
- FDA 510(k) database K230074
- FDA 510(k) database K223396
- FDA 510(k) database K220499
Across registries
- FDA 510(k) K230074 decided 27 Jul 2023 Active
- FDA GUDID UDI-DI B761R51020 listed 13 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K220499
- Cleared FDA 510(k) K223396
- Cleared FDA 510(k) K230074
- Listed FDA GUDID B761R51020
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- Withdrawn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
- 5.102
- Primary DI / UDI-DI
- B761R51020
- FDA product code
- QIH, QFM, QAS
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050, 892.2080
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiological PACS software.
- Change Healthcare Radiology Solutions 12.4.1 by Change Healthcare Canada Company
- Sidexis 4 6773258 by SIRONA Dental Systems GmbH
- ContourProtégéAI - CT Thorax 1.0 by MIM SOFTWARE INC.
- Xelis by INFINITT Healthcare Co., Ltd.
- McKesson Radiology 12.3 by Change Healthcare Canada Company
- INFINITT Cardiology PACS by INFINITT Healthcare Co., Ltd.
- Visage Ease Pro 2.2 by Visage Imaging, Inc.
- Vitrea Software Package VSTP-002A by CANON INC.