Cleared Traditional

K083740 - MAMMODIAGNOST VU

K083740 is the FDA 510(k) clearance for MAMMODIAGNOST VU by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K083740 · Philips Medical Systems Nederland B.V. · Radiology device
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Feb 2009
Decision
59d
Days
Class 2
Risk

K083740 is an FDA 510(k) clearance for the MAMMODIAGNOST VU. 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 Philips Medical Systems Nederland B.V. (Bothell, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 59 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.

View all Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K083740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2008
Decision Date February 13, 2009
Days to Decision 59 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
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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

Underwriters Laboratories, Inc.
MELISSA DEGUIA

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 1091
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083740.
NIO 2MP (MDNG-2121)
K091172 · Barco N.V. · May 2009
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NIO COLOR 3MP AND MDNC-3121
K090732 · Barco N.V. · Apr 2009
COLOR LCD MONITOR, RADIFORCE RX320
K090045 · Eizo Nanao Corporation · Jan 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · Carestream Health, Inc. · Dec 2008