Source Production & Equipment Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Source Production & Equipment Co., Inc. makes
Source Production & Equipment Co., Inc. manufactures brachytherapy sources, including 192Iridium-based models like the M-19 IR-192 and M14, as well as specialized SPEC models (M-31, M13, M23, M15, M16). These devices are designed for internal radiation therapy, delivering precise doses to treat cancers such as prostate, cervical, or breast tumors.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These products are regulated under U.S. jurisdiction and appear in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Spec Model M-31 Ref K090366
Regimes: 510(k) Registry: 510(k)SPEC Model M13 Ref K161395
Regimes: 510(k) Registry: 510(k)SPEC Model M23 Ref K161396
Regimes: 510(k) Registry: 510(k)Spec Model M15 Ref K132969
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
SPEC Model M16 Ref K150895
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Source Production & Equipment Co., Inc., initiated on 2008-03-03. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 3 Mar 2008 Z-1717-2009 Unclassified (pre-2012) Terminated Radioactive source broke during use.
Frequently asked questions
How many devices does Source Production & Equipment Co., Inc. have in the registry?
The registry currently lists 7 devices for Source Production & Equipment Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Source Production & Equipment Co., Inc.'s devices?
Among its 7 most recently registered devices, Source Production & Equipment Co., Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Source Production & Equipment Co., Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Source Production & Equipment Co., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Source Production & Equipment Co., Inc.?
FDA recall records list 1 recall initiated by Source Production & Equipment Co., Inc., the most recent initiated on 3 Mar 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Source Production & Equipment Co., Inc. in the registry?
The most recently registered devices listed for Source Production & Equipment Co., Inc. include SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE, SPEC MODEL M-31, SPEC Model M13 and SPEC Model M23.