ThermPix
Basic Information
- Brand Name
- ThermPix
- Primary DI
- 00860008801906
- Version / Model
- TPix-01
- Company Name
- USA THERM, INC.
- Labeler DUNS
- 111441897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-27
- Public Version
- 1
- Public Version Date
- 2026-02-04
- Public Version Status
- New
- Public Device Record Key
- eb5ca2ea-746f-4349-b6b9-9a2b17af5af4
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | Obstetrics/Gynecology | 884.2980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40803 | Infrared thermography system | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008801906 | GS1 |
Customer Contacts
- Phone
- (844) 998-4376
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232462 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius