DeviceClearance

Synapse PACS— 510(k) K190232

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K190232 for Synapse PACS, Substantially Equivalent on 2019-03-26. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant
Fujifilm Corporation
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
Minato-Ku, Tokyo, JP
Download summary PDFView on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Fujifilm Corporation

view all

Adverse 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 K190232

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190232.

Data sourced from openFDA. This site is unofficial and independent of the FDA.