| Device Type ID | 5265 |
| Device Name | System, Telethermographic (adjunctive Use) |
| Regulation Description | Telethermographic System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.2980 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LHQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5265 |
| Device | System, Telethermographic (adjunctive Use) |
| Product Code | LHQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Telethermographic System. |
| CFR Regulation Number | 884.2980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALFA THERMODIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIRSTSENSE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Med-Hot Thermal Imaging, Inc. | II | May-09-2017 |