510(k) K083520 ยท LLZ System, Image Processing, Radiological
INTELEPACS, MODEL VERSION 3.X.X
| Applicant | Intelerad Medical Systems Incorporated, Montreal, Qb, CA |
| Decision | Substantially Equivalent, Jun 23, 2009 |
| Received | Nov 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2014 | Intelerad Medical Systems IntelePACS software versions 3-8-1 to 4-9-1,
Product Usage:
IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.