COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
FDA 510(k) clearance K042605 · decided 2004-10-08
Clearance details
- K-number
- K042605
- Device name
- COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
- Applicant
- Siemens AG Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2004-09-24
- Decision date
- 2004-10-08
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- NWE
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Erlangen, DE
- Third-party review
- Yes
- 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 |
| COLONCAD API 3.1 (K083423) | Medicsight Plc | 2011-05-17 |
| COLON CAR 1.2 (K042674) | Medicsight | 2004-10-19 |
Recalls involving this device
No recalls on record reference this clearance.