DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA— 510(k) K852284

Substantially Equivalent

Digirad Corp.

FDA 510(k) clearance K852284 for DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA, Substantially Equivalent on 1985-11-14. Applicant: Digirad Corp..

Clearance details

Applicant: Digirad Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1985-05-29
Decision date: 1985-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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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.