510(k) K011987 ยท IZH System, X-Ray, Mammographic
MODIFIED M-IV MAMMOGRAPHY SYSTEM
| Applicant | Lorad, A Hologic Co., Danbury CT, US |
| Decision | Substantially Equivalent, Jul 11, 2001 |
| Received | Jun 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2014 | Hologic, Inc. Hologic M-IV Mammography System; Model M4--00001.
Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast. Terminated |
IZH | None listed |
| Aug 11, 2004 | Lorad, A Division of Hologic Lorad M-IV Mammography System Terminated |
IZH | None listed |
| Aug 11, 2004 | Lorad, A Division of Hologic Lorad MIV Platinum Mammograpgy System Terminated |
IZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.