Cleared Traditional

K093480 - CUATTRO UNOMD

K093480 is an FDA 510(k) clearance for CUATTRO UNOMD, manufactured by Cuattro, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K093480 · Cuattro, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
116d
Days
Class 2
Risk

K093480 is an FDA 510(k) clearance for the CUATTRO UNOMD. 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 Cuattro, LLC (Hoptacong, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 116 days - within the typical 510(k) review window.

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 - K093480

510(k) Number K093480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2009
Decision Date March 05, 2010
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
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

Regulatory Technology Services, LLC
MARK JOB

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 2242
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K093480.
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
K092427 · Albert Davydov Dds PC Professional · Mar 2010
CARESTREAM IMAGE SUITE
K100094 · Carestream Heatlh, Inc. · Mar 2010
STEREOS WORKSTATION
K090050 · Biospace Med · Mar 2010
SYNGO.PLAZA
K093612 · Siemens AG Medical Solutions · Mar 2010
COLOR LCD MONITOR, MODEL RADIFORCE RS210
K092613 · Eizo Nanao Corporation · Mar 2010
ECHOPLAQUE
K092842 · Indec Systems, Inc. · Mar 2010