COLONCAD API 3.1
FDA 510(k) clearance K083423 · decided 2011-05-17
Clearance details
- K-number
- K083423
- Device name
- COLONCAD API 3.1
- Applicant
- Medicsight Plc
- Decision
- Substantially Equivalent
- Date received
- 2008-11-19
- Decision date
- 2011-05-17
- Days to decision
- 909 days
- Clearance type
- Traditional
- Product code
- NWE
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- London, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNGO.CT COLONOGRAPHY (K140920) | Siemens Medical Solutions USA, Inc. | 2014-12-03 |
| COLON CAR 1.2 (K042674) | Medicsight | 2004-10-19 |
| COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K042605) | Siemens AG Medical Solutions | 2004-10-08 |
Recalls involving this device
No recalls on record reference this clearance.