510(k) K212186
K212186 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "Philips Radiology Smart Assistant". The FDA issued a decision of Substantially Equivalent on Dec 13, 2021. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Philips Medical Systems Dmc GmbH has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2021
- Date Received
- Jul 13, 2021
- 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
- 510(k)