DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)— 510(k) K942264

Name: FDA 510(k) clearance K942264
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

Eigen Video

FDA 510(k) clearance K942264 for DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION), Substantially Equivalent on 1994-07-20. Applicant: Eigen Video. Device class: 2.

Clearance details

Applicant: Eigen Video
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1994-05-09
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, 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 →

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

Clearance details

Recent devices under product code JAA

More clearances from Eigen Video

Adverse events under product code JAA