510(k) K052251
K052251 is an FDA 510(k) premarket notification submitted by Agfa Corporation for the device "DRYSTAR MODEL 5500". The FDA issued a decision of Substantially Equivalent on August 31, 2005. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Agfa Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2005
- Date Received
- August 18, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type