510(k) K925725
K925725 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR". The FDA issued a decision of Substantially Equivalent on February 26, 1993. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1993
- Date Received
- November 13, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1710
- Review Panel
- RA
- Submission Type