I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)— 510(k) K112180

Substantially Equivalent

Infimed, Inc.

FDA 510(k) clearance K112180 for I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP), Substantially Equivalent on 2011-08-10. Applicant: Infimed, Inc..

Clearance details

Applicant: Infimed, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2011-07-28
Decision date: 2011-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Liverpool, NY, US

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Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.