Synapse Cardiovascular— 510(k) K151859
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K151859 for Synapse Cardiovascular, Substantially Equivalent on 2015-08-12. Applicant: Fujifilm Medical Systems U.S.A, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code LLZ
view allMore clearances from Fujifilm Medical Systems U.S.A, Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 K151859
K-number listed on FDA's recall record- Z-1172-2024 — Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
- Z-1775-2021 — Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151859.
Data sourced from openFDA. This site is unofficial and independent of the FDA.