510(k) K111324
K111324 is an FDA 510(k) premarket notification submitted by Agfa Healthcare N.V. for the device "CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER". The FDA issued a decision of Substantially Equivalent on Dec 22, 2011. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Agfa Healthcare N.V. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2011
- Date Received
- May 11, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Full Field Digital, System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1715
- Review Panel
- RA
- Submission Type