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.
510(k) K200221
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200221 | Date28 Feb 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5700
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a System, Applicator, Radionuclide, Remote-Controlled for high-dose-rate (HDR) brachytherapy, designed to deliver precise radiation therapy to gynecological targets. The applicators include tandem and ovoid configurations, split rings, segmented vaginal applicators, and specialized sets for endometrial and cervical applications, ensuring compatibility with computed tomography (CT), fluoroscopy (F/S), and digital subtraction (D/S) imaging modalities.
The applicators are intended for single-use in radiology settings and are compatible with MRI environments. They are supplied sterile and include sizes tailored for specific anatomical applications, such as the CT HDR Ring & Tandem Applicator with Rectal Retractor. Authorized under FDA 510(k) clearance (K200221) as a Class II device under regulation 892.5700, these applicators are regulated for use in high-dose-rate brachytherapy procedures.