510(k) K963789
- Device
- DTX-100 BONE DENSITOMETER
- Applicant
- OSTEOMETER MEDITECH A/S
- 510(k) number
- K963789
- Product code
- KGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-14
- Date received
- 1996-09-20
- Regulation
- 892.1170
- Classification name
- Densitometer, Bone
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- BERT HUDSON
- Address
- 3003 Lbj Fwy. Suite 100 Dallas TX US 75234 75234
FDA Registration Numbers
- 9616391
- 3036666444
- 3010703925
- 3008496839
- 3015276088
- 3031503890
- 3039211310
- 3010687441
- 3026043045
- 3005496266
- 3003600763
- 3004977335
- 3008921184
- 3010208539
- 2939827
- 3023003446
- 2183066
- 3019373577
- 9616047
- 3008632256
Source Documents
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| K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-04-20 |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-12-02 |
| K152299 | TBS iNsight | Medimaps Group SA | 2016-04-29 |
| K140342 | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | Mindways Software, Inc. | 2014-08-29 |
| K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | Ge Medical Systems Ultrasound & Primary Care Diagn | 2014-05-15 |
| K130277 | SINGLE ENERGY (SE) FEMUR EXAMS | Hologic, Inc. | 2013-05-31 |
| K121716 | TBS INSIGHT | Medimaps Group SA | 2012-10-05 |
Legacy Summary
summary
FDA Review
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