EP 3000— 510(k) K924879

Name: FDA 510(k) clearance K924879
Creator: U.S. Food and Drug Administration
Published: 1993-01-04

Substantially Equivalent

Oec-Diasonics, Inc.

FDA 510(k) clearance K924879 for EP 3000, Substantially Equivalent on 1993-01-04. Applicant: Oec-Diasonics, Inc.. Device class: 2.

Clearance details

Applicant: Oec-Diasonics, Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1992-09-28
Decision date: 1993-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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

More clearances from Oec-Diasonics, Inc.

view all

K926056 — 9600 FLUOROSCOPIC IMAGING SYSTEM1993-01-21
K914446 — UROVIEW 2000, MODIFICATION1992-01-10
K896583 — F.A.S.T. TABLE1990-03-01
K893475 — UROVIEW II1989-08-10
K872022 — UROVIEW1987-07-16

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.