510(k) K072680
K072680 is an FDA 510(k) premarket notification submitted by Agfa Healthcare Corporation for the device "DRYSTAR AXYS, MODEL EYZ4E". The FDA issued a decision of Substantially Equivalent on October 25, 2007. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Agfa Healthcare Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2007
- Date Received
- September 24, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type