PXI (PERSONAL X-RAY IMAGER) 512— 510(k) K881993

Substantially Equivalent

Oklahoma Digital Technologies, Inc.

FDA 510(k) clearance K881993 for PXI (PERSONAL X-RAY IMAGER) 512, Substantially Equivalent on 1988-09-19. Applicant: Oklahoma Digital Technologies, Inc..

Clearance details

Applicant: Oklahoma Digital Technologies, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1988-05-12
Decision date: 1988-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, 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.