PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9— 510(k) K023112
Substantially EquivalentProblem Solving Concepts, Inc.
FDA 510(k) clearance K023112 for PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9, Substantially Equivalent on 2002-12-17. Applicant: Problem Solving Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Problem Solving Concepts, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DQK
view allMore clearances from Problem Solving Concepts, Inc.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K023112
K-number listed on FDA's recall record- Z-1611-2015 — 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
- Z-1612-2015 — 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, Diagnostic, Programmable
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023112.
Data sourced from openFDA. This site is unofficial and independent of the FDA.