510(k) K193431
K193431 is an FDA 510(k) premarket notification submitted by Vision Rt, Ltd. for the device "AlignRT Plus". The FDA issued a decision of Substantially Equivalent on January 3, 2020. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Vision Rt, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2020
- Date Received
- December 10, 2019
- Clearance Type
- Special
- 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