CA-1500— 510(k) K040028

Substantially Equivalent

R2 Technology, Inc.

FDA 510(k) clearance K040028 for CA-1500, Substantially Equivalent on 2004-01-22. Applicant: R2 Technology, Inc..

Clearance details

Applicant: R2 Technology, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-01-08
Decision date: 2004-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.