Model: GATECT-RT 1.0
DI: 05056190501365
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ea46290e-6c89-4e5f-a06a-1c9e24297a3a
Distribution Status:
In Commercial Distribution
DUNS Number:
222160801
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:
05056190501365
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47816
Name: Radiological video camera patient positioning/tracking system
Definition:
An assembly of hardware and software devices intended to use light-based (e.g., infrared, visible light) image acquisition to create three-dimensional (3-D) surfaces of a patient anatomy (e.g., head) to monitor patient position during diagnostic imaging, radiation treatment planning, and/or radiation therapy without the use of patient markers. It includes a camera(s), workstation, and appropriate software.
FDA Product Codes
IYE
Accelerator, Linear, Medical
Premarket Submissions
Submission Number:
K072171
Supplement Number:
000