Model: IRIS 640
Catalog: 1706400
DI: B783706400170601185
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Digital thermal imaging camera
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3c7b74e8-5086-490a-8571-6d3dde42a4aa
Distribution Status:
In Commercial Distribution
DUNS Number:
118282031
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:
B783706400170601185
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 40803
Name: Infrared thermography system
Definition:
A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units.
FDA Product Codes
LHQ
System, Telethermographic (Adjunctive Use)
Premarket Submissions
Submission Number:
K003332
Supplement Number:
000