COLON CAR 1.2
FDA 510(k) clearance K042674 · decided 2004-10-19
Clearance details
- K-number
- K042674
- Device name
- COLON CAR 1.2
- Applicant
- Medicsight
- Decision
- Substantially Equivalent
- Date received
- 2004-09-29
- Decision date
- 2004-10-19
- Days to decision
- 20 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Medicsight
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| COLONCAD API 3.1 (K083423) | Medicsight Plc | 2011-05-17 |
| 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.