HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)— 510(k) K964990

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K964990 for HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30), Substantially Equivalent on 1997-02-26. Applicant: Hitachi Medical Systems America, Inc..

Clearance details

Applicant
Hitachi Medical Systems America, Inc.
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rockville, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JAA

product code JAA
Other
1
Total
1

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 →

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