Cleared Traditional

K080320 - PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300

K080320 is an FDA 510(k) clearance for PRIMEVUE 21 3MP COLOR DISPLAY, manufactured by Nds Surgical Imaging. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K080320 · Nds Surgical Imaging · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
15d
Days
Class 2
Risk

K080320 is an FDA 510(k) clearance for the PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300. 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 Nds Surgical Imaging (San Jose, US). The FDA issued a Cleared decision on February 21, 2008 after a review of 15 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 - K080320

510(k) Number K080320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2008
Decision Date February 21, 2008
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2241
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K080320.
XVIEWNET
K080290 · American Radiologist Network, Inc. · Feb 2008
IMAGEGRID
K080333 · Candelis, Inc. · Feb 2008
I-DIXEL
K073704 · J. Morita USA, Inc. · Feb 2008
INSTARAD
K080334 · Medsphere Technologies Pvt , Ltd. · Feb 2008
VITREA 4DCT
K072821 · Vital Images, Inc. · Feb 2008
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
K073007 · Barcoview, Medical Imaging Systems · Feb 2008