Definition: A Bone Sonometer Is A Device That Transmits Ultrasound Energy Into The Human Body To Measure Acoustic Properties Of Bone That Indicate Overall Bone Health And Fracture Risk. The Primary Components Of The Device Are A Voltage Generator, A Transmitting
| Device Type ID | 5393 |
| Device Name | Bone Sonometer |
| Regulation Description | Bone Sonometer. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1180 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MUA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5393 |
| Device | Bone Sonometer |
| Product Code | MUA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Sonometer. |
| CFR Regulation Number | 892.1180 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CYBERLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |