| Device Type ID | 5367 |
| Device Name | Densitometer, Bone |
| Regulation Description | Bone Densitometer. |
| 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 | 892.1170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KGI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5367 |
| Device | Densitometer, Bone |
| Product Code | KGI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Densitometer. |
| CFR Regulation Number | 892.1170 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIMAPS GROUP SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MINDWAYS SOFTWARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 9 |
Poor Quality Image | 8 |
Device Stops Intermittently | 5 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Use Of Device Problem | 1 |
Computer Software Problem | 1 |
| Total Device Problems | 25 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | II | Apr-17-2018 |
| 2 | Medimaps Group | II | Nov-05-2016 |