RFA A-300— 510(k) K934303

Substantially Equivalent

Scanditronix, Inc.

FDA 510(k) clearance K934303 for RFA A-300, Substantially Equivalent on 1994-08-09. Applicant: Scanditronix, Inc..

Clearance details

Applicant: Scanditronix, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1993-09-01
Decision date: 1994-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.