510(k) K221853
K221853 is an FDA 510(k) premarket notification submitted by Konica Minolta Healthcare Americas, Inc. for the device "OTC DDR". The FDA issued a decision of Substantially Equivalent on July 27, 2022. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Konica Minolta Healthcare Americas, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2022
- Date Received
- June 27, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type