PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9
FDA 510(k) clearance K023112 · decided 2002-12-17
Clearance details
- K-number
- K023112
- Device name
- PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9
- Applicant
- Problem Solving Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-19
- Decision date
- 2002-12-17
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Commu recall (Z-1611-2015) | Fujifilm Medical Systems U.S.A., Inc. | 2015-05-14 |
| Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Syn recall (Z-1612-2015) | Fujifilm Medical Systems U.S.A., Inc. | 2015-05-14 |