510(k) K012355 ยท EHD Unit, X-Ray, Extraoral With Timer
IMAGE-X SYSTEM
| Applicant | Tg Group, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Aug 9, 2001 |
| Received | Jul 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012355
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.