510(k) K013667 ยท KPS System, Tomography, Computed, Emission
BCC GAMMA CAMERA
| Applicant | Is2 Research, Inc., Nepean, Ontario, CA |
| Decision | Substantially Equivalent, Jan 28, 2002 |
| Received | Nov 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013667
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.