Rapid (6.0)
510(k) K233512
Rapid (6.0) is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by iSchemaView, Inc., cleared under FDA 510(k) K233512 on 16 Jan 2024, 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 | FDA 510(k)SESE | NumberK233512 | Date16 Jan 2024 | StatusActive |
Official records
- FDA 510(k) database K233512
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K233512
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Rapid 6.x | 6.x | B761R60 | — | On the market |
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Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).
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