Cleared Traditional

NinesMeasure (K202990) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202990 · Nines, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
148d
Days
Class 2
Risk

K202990 is an FDA 510(k) clearance for the NinesMeasure. 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 Nines, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 25, 2021 after a review of 148 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.

View all Nines, Inc. devices

Submission Details

510(k) Number K202990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date February 25, 2021
Days to Decision 148 days
Submission Type Traditional
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
41d slower than avg
Panel avg: 107d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Hogan Lovells US LLP
John J. Smith

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 819
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K202990.
Quicktome
K203518 · Omniscient Neurotechnology Pty Ltd (O8t) · Mar 2021
SubtleMR
K203182 · Subtle Medical, Inc. · Feb 2021
Cuptimize
K203651 · Cuptimize, Inc. · Feb 2021
MyPAO Planning Report
K200589 · Medacta International S.A. · Feb 2021
TruPlan
K202212 · Circle Cardiovascular Imaging, Inc. · Feb 2021
PhantomMSK Hip
K210136 · OrthoGrid Systems, Inc. · Feb 2021