510(k) K140920
K140920 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SYNGO.CT COLONOGRAPHY". The FDA issued a decision of Substantially Equivalent on December 3, 2014. The device falls under product code NWE (Colon Computed Tomography System, Computer Aided Detection), a Class II device regulated under 21 CFR 892.2050. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2014
- Date Received
- April 10, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colon Computed Tomography System, Computer Aided Detection
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.