# K052947: Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source

- Pathway: 510(k) (Traditional)
- Applicant: Source Production & Equipment Co., Inc.
- Decided: Apr 19, 2006 after 181 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864210 (1986). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030745: Gammamed 212 and 232 Source Assembly, Varian Medical Systems (2003) Summary page 1.
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.
- K991571: 10 Curie Irdium 192, CSN00100-192, Alpha-Omega Services, Inc. (2000) Summary page 1.

## Most influential descendants
- K092522: ACU007S (2009), 0 descendants of its own

## Recalls of this device
- Mar 3, 2008 · Not classified · Z-1717-2009: Radioactive source broke during use.

## Indications for use
Source Production & Equipment Co., Inc. (SPEC) Model M-19 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, hlng, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.

Source page: https://510kreport.com/device/K052947
Methodology: https://510kreport.com/methodology