DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)— 510(k) K993532

Substantially Equivalent

Impax Technology, Inc.

FDA 510(k) clearance K993532 for DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES), Substantially Equivalent on 1999-12-15. Applicant: Impax Technology, Inc..

Clearance details

Applicant: Impax Technology, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1999-10-19
Decision date: 1999-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterloo, Ontario, CA

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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.