Cleared Traditional

K253560 - Enhanced Boundary for PCCT

K253560 is an FDA 510(k) clearance for Enhanced Boundary for PCCT, manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K253560 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
219d
Days
Class 2
Risk

K253560 is an FDA 510(k) clearance for the Enhanced Boundary for PCCT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on June 24, 2026 after a review of 219 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems, LLC devices

FDA 510(k) Submission Details - K253560

510(k) Number K253560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date June 24, 2026
Days to Decision 219 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
112d slower than avg
Panel avg: 107d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K253560.
CardIQ Suite
K253770 · GE Medical Systems SCS · Jul 2026
Respiratory Gating for Scanners (2.1)
K253026 · Varian Medical Systems, Inc. · Jun 2026
Aquilion ONE (TSX-308A/TSX-306A) V2.0
K253596 · Canon Medical Systems Corporation · May 2026
Spectral CT Verida Family
K253649 · Philips Medical Systems Technologies , Ltd. · Mar 2026
CT Rembra RT
K252992 · Philips Healthcare (Suzhou) Co., Ltd. · Mar 2026
True Definition DL
K253686 · Ge Healthcare Japan Corporation · Mar 2026