Device
SIGNA Sprint Select System Medical Device
Manufacturer
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
Model: SIGNA Sprint Select
DI: 00195278925282
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
SIGNA Sprint Select System Medical Device
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1cee8da2-aa71-46d0-86ca-6135209ca1b9
Distribution Status:
In Commercial Distribution
DUNS Number:
421356265
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00195278925282
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37654
Name: Full-body MRI system, superconducting magnet
Definition:
A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.
FDA Product Codes
MOS
Coil, Magnetic Resonance, Specialty
LNH
System, Nuclear Magnetic Resonance Imaging
LNI
System, Nuclear Magnetic Resonance Spectroscopic
Premarket Submissions
Submission Number:
K253779
Supplement Number:
000