510(k) K122286 ยท MUE Full Field Digital, System, X-Ray, Mammographic
MAMMOMAL INSPIRATION
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Feb 22, 2013 |
| Received | Jul 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2017 | Siemens Medical Solutions USA, Inc Mammomat Inspiration full, field digital,system,x-ray,mammographic
Product Usage:
The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies un Terminated |
MUE | None listed |
| Dec 6, 2014 | Siemens Medical Solutions USA, Inc Mammomat Inspiration system:
Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted Terminated |
MUE | None listed |
| Oct 17, 2014 | Siemens Medical Solutions USA, Inc Siemens Mammomat Inspiration mammography systems.
The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical Terminated |
MUE | None listed |
| May 20, 2014 | Siemens Medical Solutions USA, Inc MAMMOMAT Inspiration.
Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Terminated |
MUE | None listed |
| Jul 11, 2013 | Siemens Medical Solutions USA, Inc Siemens Mammomat Inspiration - full-field digital mammography
Product Usage: Mammography Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.