EXL-22DP X-RAY RADIATION THERAPY SYSTEM— 510(k) K873398

Substantially Equivalent

Mitsubishi Intl. Corp.

FDA 510(k) clearance K873398 for EXL-22DP X-RAY RADIATION THERAPY SYSTEM, Substantially Equivalent on 1988-04-29. Applicant: Mitsubishi Intl. Corp..

Clearance details

Applicant: Mitsubishi Intl. Corp.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1987-08-24
Decision date: 1988-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

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.