510(k) DEN180005
- Device
- OsteoDetect
- Applicant
- Imagen Technologies, Inc.
- 510(k) number
- DEN180005
- Product code
- QBS
- Decision
- Unknown (DENG)
- Decision date
- 2018-05-24
- Date received
- 2018-02-05
- Regulation
- 892.2090
- Classification name
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alex Dresner
- Address
- 33 E. 33rd St., Suite 506 New York NY US 10016 10016
FDA Registration Numbers#
- 9616047
- 2126677
- 3026753394
- 3027453703
- 3014661828
- 3013427569
- 3021907554
- 3007734888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QBS#
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|---|---|---|---|
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| K240712 | icobrain aria | Icometrix NV | 2024-11-07 |
| K240845 | Rayvolve | Azmed Sas | 2024-07-17 |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC | 2023-05-25 |
| K222176 | BoneView | Gleamer | 2023-03-02 |
| K220164 | Rayvolve | Azmed Sas | 2022-06-02 |
| K212365 | BoneView | Gleamer | 2022-03-01 |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020-07-30 |