Revolution CT— 510(k) K163213
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K163213 for Revolution CT, Substantially Equivalent on 2016-12-16. Applicant: Ge Medical Systems, LLC. Device class: 2.
Clearance details
- 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
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code JAK
view allMore clearances from Ge Medical Systems, LLC
view allAdverse 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 K163213
K-number listed on FDA's recall record- Z-2150-2026 — Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
- Z-2153-2026 — Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
- Z-2154-2026 — Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
- Z-1297-2025 — GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
- Z-1303-2025 — GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
- Z-0242-2022 — Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- Z-0815-2022 — Revolution Apex, Revolution CT with Apex Edition
- Z-0816-2022 — Revolution CT, Revolution CT ES
- Z-2021-2021 — The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
- Z-2022-2021 — The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
- Z-2004-2021 — Revolution CT
- Z-1129-2021 — System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
- Z-1130-2021 — System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
- Z-1951-2019 — Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Z-0776-2019 — Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Z-2582-2018 — Revolution CT 160 1.5D STD WAUK
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163213.
Data sourced from openFDA. This site is unofficial and independent of the FDA.