PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX— 510(k) K082167

Name: FDA 510(k) clearance K082167
Creator: U.S. Food and Drug Administration
Published: 2008-09-26

Substantially Equivalent

Digimed Corporation

FDA 510(k) clearance K082167 for PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX, Substantially Equivalent on 2008-09-26. Applicant: Digimed Corporation. Device class: 2.

Clearance details

Applicant: Digimed Corporation
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2008-07-31
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K082167

K-number listed on FDA's recall record

Z-2117-2025 — Portable X-ray systemClass II·Ongoing·DIGIMED CO., LTD·20250619

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082167.

Data sourced from openFDA. This site is unofficial and independent of the FDA.