# K052351: HDR Iort Shielded Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Oct 17, 2005 after 49 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864210 (1986). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961601: H.a.M. Applicator, Mick Radio-Nuclear Instruments, Inc. (1996) Summary page 1.
- K001544: Vaginal Applicator Shielded, Mick Radio-Nuclear Instruments, Inc. (2000) Summary page 1.
- K011690: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2002) Summary page 1.
- K030558: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2003) Summary page 1.

## Most influential descendants
- K062135: Art Shielded Breast Applicator (2006), 0 descendants of its own

## Indications for use
The Mick ItDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicator for the positioning of IIDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.

Source page: https://510kreport.com/device/K052351
Methodology: https://510kreport.com/methodology