Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Revolution Ascend

K-Number: K213938 · 2022-02-04

ApplicantGe Healthcare Japan Corporation
Decision Date2022-02-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Revolution Ascend is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213938. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revolution Ascend?

Revolution Ascend is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K213938.

When did Revolution Ascend receive FDA 510(k) clearance?

Revolution Ascend received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213938.

Who is the listed applicant for Revolution Ascend?

The FDA 510(k) record lists Ge Healthcare Japan Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revolution Ascend?

The FDA product code for Revolution Ascend is JAK.

Other records listing Ge Healthcare Japan Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253686True Definition DLK233698True Enhance DLK230807Deep Learning Image ReconstructionK220961Deep Learning Image ReconstructionK212067Deep Learning Image ReconstructionK203169Revolution Ascend

View all 8 devices →

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑