DI2000/HS-45-150 X-RAY TUBE INSERT— 510(k) K910842

Substantially Equivalent

Comet Ltd. C/O Radiology Resources, Inc.

FDA 510(k) clearance K910842 for DI2000/HS-45-150 X-RAY TUBE INSERT, Substantially Equivalent on 1991-03-06. Applicant: Comet Ltd. C/O Radiology Resources, Inc..

Clearance details

Applicant: Comet Ltd. C/O Radiology Resources, Inc.
Product code: Code ITY
Advisory panel: Radiology
Date received: 1991-02-27
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Switzerland, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITY

product code ITY

Other: 1
Total: 1

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.