510(k) K023112 ยท DQK Computer, Diagnostic, Programmable
PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9
| Applicant | Problem Solving Concepts, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 17, 2002 |
| Received | Sep 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse Cardiovascular I ProSolv CardioVascular
Synapse Cardiovascular v4.0.8
Synapse Cardiovascular v4.0.8 SR1
Intended Use:
Picture Archiving and Communication System
Computer, Diagnosti Terminated |
DQK | None listed |
| May 14, 2015 | Fujifilm Medical Systems U.S.A., Inc. FujiMedical Synapse Cardiovascular I ProSolv CardioVascular.
A picture Archiving and Communication System
Software versions:
Synapse Cardiovascular v4.0.8
Synapse Cardiovascular v4.0.8 SR1 Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.