Device
Revolution Spectra 80 - Designated System Medical Device
Manufacturer
GE Medical Systems, L.L.C.
GE Medical Systems, L.L.C.
Model: Spectra
Catalog: 5590000-50
DI: 00198953085950
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Revolution Spectra 80 - Designated System Medical Device
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f9cc336f-1ece-4a07-8995-11c92d5c7a91
Distribution Status:
In Commercial Distribution
DUNS Number:
144879404
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00198953085950
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37618
Name: Full-body CT system
Definition:
An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.
FDA Product Codes
JAK
System, X-Ray, Tomography, Computed
Premarket Submissions
Submission Number:
K253520
Supplement Number:
000