| Device Type ID | 5261 |
| Device Name | System, Thermographic, Liquid Crystal, Powered (adjunctive Use) |
| Regulation Description | Liquid Crystal Thermographic System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | PMA |
| CFR Regulation Number | 884.2982 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KXZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |