510(k) K220338
K220338 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "ExacTrac Dynamic". The FDA issued a decision of Substantially Equivalent on Apr 29, 2022. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Brainlab AG has 141 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 29, 2022
- Date Received
- Feb 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)