510(k) K233381
K233381 is an FDA 510(k) premarket notification submitted by Carestream Health, Inc. for the device "DRX-Evolution Plus System". The FDA issued a decision of Substantially Equivalent on March 12, 2024. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Carestream Health, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2024
- Date Received
- October 2, 2023
- Clearance Type
- Traditional
- 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