Cleared Traditional

K261531 - PV-iCurve Pro

K261531 is an FDA 510(k) clearance for PV-iCurve Pro, manufactured by Perception Vision Medical Technology Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K261531 · Perception Vision Medical Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
166d
Days
Class 2
Risk

K261531 is an FDA 510(k) clearance for the PV-iCurve Pro. 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 Perception Vision Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 21, 2026 after a review of 166 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.

FDA 510(k) Submission Details - K261531

510(k) Number K261531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2026
Decision Date October 21, 2026
Days to Decision 166 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
59d slower than avg
Panel avg: 107d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LLZ System, Image Processing, Radiological

All 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K261531.
Vitrea Advanced Visualization, Version 7.16
K263648 · Canon Medical Informatics, Inc. · Oct 2026
MIM – KineticID
K261763 · Mim Software, Inc. · Oct 2026
Eden PACS
K261788 · Higia., Inc. d/b/a Eden · Oct 2026
Syngo Carbon Space (VA4)
K263048 · Siemens Healthineers AG · Sep 2026
Syneris PACS v.1.0.1.0
K261874 · Syneris · Sep 2026
HipStudio Analysis
K262442 · Replasia BV · Sep 2026
K261531 · PV-iCurve Pro
Download PDF FDA Summary Perception Vision Med…