510(k) K042605
K042605 is an FDA 510(k) premarket notification submitted by Siemens AG Medical Solutions for the device "COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY". The FDA issued a decision of Substantially Equivalent on October 8, 2004. 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 AG Medical Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2004
- Date Received
- September 24, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- Yes
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.