Summit World Trade Corp.
United StatesFDA applicant, unverified
- Devices
- 10
What Summit World Trade Corp. makes
Summit World Trade Corp. manufactures magnetic resonance (MR) diagnostic devices and associated coils, including 3-D Fourier transform reconstruction head coils, 2-D inflow MR angiography systems, and supplemental radiofrequency (R/F) coils for head imaging. Their portfolio includes both fixed and mobile MR diagnostic devices, as well as software upgrades for existing systems.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company’s products are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulatory requirements. The manufacturer is based in the United States.
Catalogue
Mrp-20: Hs/Mr Head Coil 3-D Ft Reconstruction Ref K903203
Regimes: 510(k) Registry: 510(k)Mrp-5000(1): 2-D Inflow Mr Angiography Ref K905833
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Magnetic Resonance Diagnostic Device Mrp-20 Ref K894016
Regimes: 510(k) Registry: 510(k)Mrp-7000(1) : 2-D Inflow Mr Angiography Ref K905834
Regimes: 510(k) Registry: 510(k)Mrp -5000(1): Version 2.0 Software Ref K905832
Regimes: 510(k) Registry: 510(k)Mrp-7000: Supplemental R/F Coils Ref K905835
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Summit World Trade Corp. have in the registry?
The registry currently lists 10 devices for Summit World Trade Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Summit World Trade Corp.'s devices?
Among its 10 most recently registered devices, Summit World Trade Corp. has devices listed in FDA 510(k) (10 devices).
What risk classes do Summit World Trade Corp.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Summit World Trade Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Summit World Trade Corp. in the registry?
The most recently registered devices listed for Summit World Trade Corp. include MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION, MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY, MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS and MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL.