EXPOSCOP MOBILE IMAGING SYSTEM— 510(k) K851031

Name: FDA 510(k) clearance K851031
Creator: U.S. Food and Drug Administration
Published: 1985-05-28

Substantially Equivalent

Euro-Electronics, Inc.

FDA 510(k) clearance K851031 for EXPOSCOP MOBILE IMAGING SYSTEM, Substantially Equivalent on 1985-05-28. Applicant: Euro-Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Euro-Electronics, Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1985-03-12
Decision date: 1985-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAA

view all

K253103 — Nexus DRF Digital X-ray Imaging System2026-05-29
K251650 — Insight Enhanced DRF (EN-1002-01)2025-09-16
K242488 — Soteria E-View2025-01-06
K242948 — Adora DRFi (04550010)2024-12-23
K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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 →

Recalls naming K851031

K-number listed on FDA's recall record

Z-0562-2014 — Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImagingClass II·Terminated·Ziehm Imaging Inc·20131121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K851031.

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