510(k) K173578 ยท KPS System, Tomography, Computed, Emission
Biograph mCT Family of PET/CT Systems
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Dec 20, 2017 |
| Received | Nov 20, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2018 | Siemens Medical Solutions USA, Inc. Biograph mCT:
a) S(64)-3R, Material Number 10248669
b) S (20) -3R, Material Number 10507786
c) Flow 20-4R, Material Number 10528958
d) m Flow 64-4R, Material Number 10529161
e) mCT S(40)-4R, Materia Terminated |
KPS | None listed |
| Jun 8, 2018 | Siemens Medical Solutions USA, Inc. Biograph mCT Systems:
(a) Biograph mCT S(64)-3R, Material Number 10248669
Product Usage:
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positro Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.