510(k) K100692
K100692 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "DIGITAL SPOT MAMMOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 6, 2010. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2010
- Date Received
- March 10, 2010
- Clearance Type
- Special
- 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