Cleared Traditional

K213938 - Revolution Ascend (FDA 510(k) Clearance)

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

K213938 · Ge Healthcare Japan Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
50d
Days
Class 2
Risk

K213938 is an FDA 510(k) clearance for the Revolution Ascend. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Healthcare Japan Corporation (Hino, JP). The FDA issued a Cleared decision on February 4, 2022 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Healthcare Japan Corporation devices

Submission Details

510(k) Number K213938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2021
Decision Date February 04, 2022
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 816
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K213938.
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
Photonova Spectra, Photonova Spectra Select
K253520 · Ge Medical Systems, LLC · Mar 2026
SOMATOM X.cite
K253574 · Siemens Medical Solutions USA, Inc. · Mar 2026
Extremity CT Imaging System
K252249 · Mars Bioimaging , Ltd. · Mar 2026