510(k) K200221
CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor by
Mick Radio-Nuclear Instruments, Inc.
— Product Code JAQ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2020
- Date Received
- January 29, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type