ThermPix
GUDID 00860008801906
The ThermPix® Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted. The ThermPix® Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.
USA THERM, INC.
Infrared thermography system| Primary Device ID | 00860008801906 |
| NIH Device Record Key | eb5ca2ea-746f-4349-b6b9-9a2b17af5af4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThermPix |
| Version Model Number | TPix-01 |
| Company DUNS | 111441897 |
| Company Name | USA THERM, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com | |
| Phone | (844) 998-4376 |
| sales@usatherm.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008801906 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232462
FDA Product Code
| LHQ | System, Telethermographic (Adjunctive Use) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-04 |
| Device Publish Date | 2026-01-27 |
Trademark Results [ThermPix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMPIX 88953038 not registered Live/Pending |
USA Therm, Inc. 2020-06-08 |
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