The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc with the FDA for Gehc Dxa Bone Densitometers With Encore Version 18.
| Device ID | K191112 |
| 510k Number | K191112 |
| Device Name: | GEHC DXA Bone Densitometers With EnCORE Version 18 |
| Classification | Densitometer, Bone |
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 3030 Ohmeda Drive Madison, WI 53718 |
| Contact | Martha Kamrow |
| Correspondent | Martha Kamrow GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 3030 Ohmeda Drive Madison, WI 53718 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-26 |
| Decision Date | 2019-09-19 |
| Summary: | summary |