Cleared Traditional

K261595 - Ceevra Reveal 4

K261595 is an FDA 510(k) clearance for Ceevra Reveal 4, manufactured by Ceevra, Inc.. The device is a Class 2 Radiology device with product code QIH cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K261595 · Ceevra, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
103d
Days
Class 2
Risk

K261595 is an FDA 510(k) clearance for the Ceevra Reveal 4. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Ceevra, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 25, 2026 after a review of 103 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 Ceevra, Inc. devices

FDA 510(k) Submission Details - K261595

510(k) Number K261595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2026
Decision Date August 25, 2026
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

QIH Device Classification - Class 2, Special Controls

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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 - QIH Automated Radiological Image Processing Software

All 320
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K261595.
Heartvue.Proton
K260811 · Heartvue.ai, Inc. · Aug 2026
BoneMRI
K260584 · Mriguidance B.V. · Aug 2026
DS Core CBCT Anatomy
K262127 · Dentsply Sirona · Aug 2026
Lower Limb AI (LLAI)
K261641 · AI Planning Logic, Inc. · Aug 2026
Prostate Core
K253794 · Lucida Medical, Ltd. · Aug 2026
mdprostate
K252571 · Mediaire GmbH · Aug 2026