DICOMPACS, MODEL 5— 510(k) K070618

Name: FDA 510(k) clearance K070618
Creator: U.S. Food and Drug Administration
Published: 2007-04-25

Substantially Equivalent

Oehm Und Rehbein GmbH

FDA 510(k) clearance K070618 for DICOMPACS, MODEL 5, Substantially Equivalent on 2007-04-25. Applicant: Oehm Und Rehbein GmbH. Device class: 2.

Clearance details

Applicant: Oehm Und Rehbein GmbH
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2007-03-05
Decision date: 2007-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockstock, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Oehm Und Rehbein GmbH

view all

K182317 — AMADEO M-DR mini, AMADEO M-AX mini2018-09-24
K141440 — DICOMPACS DX-R WITH FLAT PANEL2014-08-29
K131211 — DICOMPACS DX-R WITH FLAT PANEL2013-11-05
K091364 — DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.42009-12-11

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.