Cleared Traditional

K000770 - PROVIEW MEDICAL IMAGE DISPLAY MODULE

K000770 is an FDA 510(k) clearance for PROVIEW MEDICAL IMAGE DISPLAY MODULE, 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 68-day FDA review.

K000770 · Cerner Corp. · Radiology device
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May 2000
Decision
68d
Days
Class 2
Risk

K000770 is an FDA 510(k) clearance for the PROVIEW MEDICAL IMAGE DISPLAY MODULE. 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 May 16, 2000 after a review of 68 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 - K000770

510(k) Number K000770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2000
Decision Date May 16, 2000
Days to Decision 68 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 107d · This submission: 68d
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 K000770.
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001747 · Barco NV Display Systems · Jul 2000
LIFERX
K001596 · Bowdengs Technologies, LLC · Jul 2000
DIGITAL INTEGRATION SYSTEM, DIS2000
K001012 · Wellington Medical Systems, Inc. · Jun 2000
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
K000630 · Hopkins Imaging Systems, Inc. · May 2000
FOTOMASTER
K000380 · Hamilton Thorne Research · May 2000
EINSTEIN PROCESSING AND REVIEW WORKSTATION
K000395 · Ge Medical Systems F.I. Haifa · May 2000
K000770 · PROVIEW MEDICAL IMAGE DISPLAY MODULE
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