HYPERLUX 30 IMAGE SYSTEM— 510(k) K827489

Substantially Equivalent

Cgr Medical Corp.

FDA 510(k) clearance K827489 for HYPERLUX 30 IMAGE SYSTEM, Substantially Equivalent on 1982-11-04. Applicant: Cgr Medical Corp..

Clearance details

Applicant: Cgr Medical Corp.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1982-11-04
Decision date: 1982-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

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.