Cleared Traditional

K070618 - DICOMPACS, MODEL 5

K070618 is an FDA 510(k) clearance for DICOMPACS, manufactured by Oehm Und Rehbein GmbH. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K070618 · Oehm Und Rehbein GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
51d
Days
Class 2
Risk

K070618 is an FDA 510(k) clearance for the DICOMPACS, MODEL 5. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Oehm Und Rehbein GmbH (Rockstock, DE). The FDA issued a Cleared decision on April 25, 2007 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K070618

510(k) Number K070618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2007
Decision Date April 25, 2007
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K070618.
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SAPHENEIA CLARITY
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VISIO+CD VIEWER# KPSCDVE01
K070606 · Keosys Sas · Apr 2007
PATIENTGALLERY IMAGING SOFTWARE
K070954 · Raster Builders, Inc. · Apr 2007
DGSCOPE, RELEASE 1.0
K070397 · Segami Corporation · Apr 2007
K070618 · DICOMPACS, MODEL 5
Download PDF FDA Summary Oehm Und Rehbein GmbH