DeviceClearance

Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT +3 more— 510(k) K213715

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K213715 for Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT +3 more, Substantially Equivalent on 2021-12-17. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Device name as filed
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
Applicant
Ge Medical Systems, LLC
Product code
Code JAK
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Waukesha, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JAK

product code JAK
Death
27
Injury
571
Malfunction
779
Total
1,377

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K213715

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213715.

Data sourced from openFDA. This site is unofficial and independent of the FDA.