Cleared Traditional

K253831 - CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (FDA 510(k) Clearance)

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

K253831 · Cercare Medical A/S · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
168d
Days
Class 2
Risk

K253831 is an FDA 510(k) clearance for the CMN Capillary Function with Virtual Expert for MRI, CT and CBCT. 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 Cercare Medical A/S (Aarhus C, DK). The FDA issued a Cleared decision on May 18, 2026 after a review of 168 days - an extended review 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 Cercare Medical A/S devices

Submission Details

510(k) Number K253831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2025
Decision Date May 18, 2026
Days to Decision 168 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
61d slower than avg
Panel avg: 107d · This submission: 168d
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

JW Regulatory Consulting, LLC
Jennifer Willner

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 2267
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K253831.
Helion Viewer Suite
K254265 · Videomed Srl ( a Baxter Healthcare Corp company) · May 2026
SubtleHD-PET (1.x)
K254013 · Subtle Medical, Inc. · May 2026
HipGuide (V 1.0.0.0)
K260321 · Orthopedic Driven Imaging, LLC · May 2026
Neowise
K260716 · Cefla S.C. · May 2026
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K260009 · Broncus Medical, Inc. · Apr 2026
CCI PACS VIEWER (PACS-US-001)
K254237 · CliniComp, Intl. · Apr 2026