Imaging Engineering, LLC
Country not established FDA establishment FEI 3015437189
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
- GUDID
- GUDID
- GUDID
Insight Agile DRF Ref K210469
510(k) 510(k)Insight Enhanced™ DRF (EN-1002-01) Ref K251650
510(k) 510(k)Insight Enhanced DRF Digital Imaging System Ref K200396
510(k) 510(k)Insight Essentials DRF Digital Imaging System Ref K191310
510(k) 510(k)
Company details
- FDA FEI number
- 3015437189
- Address
- 4424 NW 13th Street, Gainesville, FL, 32609
Frequently asked questions
How many devices does IMAGING ENGINEERING, LLC have in the registry?
The registry currently lists 7 devices for IMAGING ENGINEERING, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list IMAGING ENGINEERING, LLC's devices?
Among its 7 most recently registered devices, IMAGING ENGINEERING, LLC has devices listed in FDA 510(k) (4 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do IMAGING ENGINEERING, LLC's devices fall under?
Among its 7 most recently registered devices, the classes recorded for IMAGING ENGINEERING, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from IMAGING ENGINEERING, LLC in the registry?
The most recently registered devices listed for IMAGING ENGINEERING, LLC include Insight Essentials DRF, Insight Enhanced DRF, Insight Agile DRF and Insight Enhanced™ DRF (EN-1002-01).