AJEX 9015/135H PORTABLE X-RAY— 510(k) K052341

Substantially Equivalent

Jpi America, Inc.

FDA 510(k) clearance K052341 for AJEX 9015/135H PORTABLE X-RAY, Substantially Equivalent on 2005-10-07. Applicant: Jpi America, Inc..

Clearance details

Applicant: Jpi America, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2005-08-26
Decision date: 2005-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.