510(k) K192405
K192405 is an FDA 510(k) premarket notification submitted by Jiangsu Rayer Medical Technology Co., Ltd. for the device "Image Guidance System for Radiotherapy". The FDA issued a decision of Substantially Equivalent on May 1, 2020. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2020
- Date Received
- Sep 3, 2019
- 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)