Rapid RV/LV
510(k) K223396
Rapid RV/LV 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) K223396 on 1 Feb 2023, 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 | NumberK223396 | Date1 Feb 2023 | StatusActive |
Official records
- FDA 510(k) database K223396
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- Withdrawn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 K223396
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 5.101 | 5.101 | B761R51011 | On the market | |
| Rapid 5.102 | 5.102 | B761R51020 | On the market | |
| Rapid 6.1.0 | 6.1.0 | B761R610 | On the market | |
| 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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