Elscint, Inc.
United StatesFDA applicant, unverified
- Devices
- 94
What Elscint, Inc. makes
Elscint, Inc. manufactures magnetic resonance imaging (MRI) systems, including the Gyrex 2T Prestige, Gyrex Privilege, and Gyrex 2T-DLX models, along with compatible head and neck coils. The company also produces diagnostic ultrasound imaging equipment, such as the Dynex-44 and SDL-100A models, as well as computed tomography (CT) scanners like the Exel 2400E and Excel CT Twin. Additionally, it supplies mammography systems, including the Mam LS-3 microfocus mammography system with magnification capabilities.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) and PMA registries. These products are listed under U.S. jurisdiction, reflecting compliance with U.S. medical device regulations.
Catalogue
Search and filter all 94 devicesShowing 1-50 of 94
Frequently asked questions
How many devices does Elscint, Inc. have in the registry?
The registry currently lists 94 devices for Elscint, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elscint, Inc.'s devices?
Among its 50 most recently registered devices, Elscint, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Elscint, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Elscint, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elscint, Inc. in the registry?
The most recently registered devices listed for Elscint, Inc. include GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102, HEAD AND NECK COIL FOR THE GYREX 2T-DLX, DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING and GYREX PRIVILEGE.