Cleared Traditional

K070394 - CERNER PROVISION WORKSTATION

K070394 is an FDA 510(k) clearance for CERNER PROVISION WORKSTATION, manufactured by Cerner Corp.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K070394 · Cerner Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
46d
Days
Class 2
Risk

K070394 is an FDA 510(k) clearance for the CERNER PROVISION WORKSTATION. 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 Cerner Corp. (Kansas City, US). The FDA issued a Cleared decision on March 27, 2007 after a review of 46 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 - K070394

510(k) Number K070394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2007
Decision Date March 27, 2007
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
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 2257
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K070394.
QLAB QUANTIFICATION
K070792 · Philips Ultrasound, Inc. · Apr 2007
CHILI PACS
K070796 · Chili GmbH · Apr 2007
INVIVODENTAL
K070803 · Anatomage, Inc. · Apr 2007
ZIOSTATION
K070205 · Ziosoft, Inc. · Mar 2007
NIO 5MP-21 AND MDNG-5121 CB
K062621 · Barcoview · Mar 2007
ONDEMAND3D
K070464 · Cybermed, Inc. · Mar 2007
K070394 · CERNER PROVISION WORKSTATION
Download PDF FDA Summary Cerner Corp.