Cleared Special

UNiD Spine Analyzer (K180091) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180091 · Medicrea International · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
27d
Days
Class 2
Risk

K180091 is an FDA 510(k) clearance for the UNiD Spine Analyzer. 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 Medicrea International (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on February 8, 2018 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Medicrea International devices

Submission Details

510(k) Number K180091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2018
Decision Date February 08, 2018
Days to Decision 27 days
Submission Type Special
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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 Peers - LLZ System, Image Processing, Radiological

All 820
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K180091.
Velocity
K173636 · Varian Medical Systems, Inc. · Feb 2018
SuRgical Planner (SRP)
K170793 · Surgical Theater, LLC · Feb 2018
SENYINT Remote Consultation System
K162727 · Dalian Senyint Digital Medical System Co., Ltd. · Feb 2018
eUnity
K172490 · Client Outlook, Inc. · Feb 2018
Insight BD
K172832 · Siemens Medi Cal Solutions, Inc. · Feb 2018
MFI-Cardiac
K173512 · Multifunctional Imaging, LLC · Feb 2018