510(k) K111566
K111566 is an FDA 510(k) premarket notification submitted by Carestream Health, Inc. for the device "DRYVIEW CHROMA IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 2011. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Carestream Health, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2011
- Date Received
- June 6, 2011
- Clearance Type
- Traditional
- 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