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FDA 510(k)

MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY

K-Number: K905833 · 1991-02-25

ApplicantSummit World Trade Corp.
Decision Date1991-02-25
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Summit World Trade Corp.. It received FDA 510(k) clearance on 1991-02-25 under 510(k) number K905833. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY?

MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY is a medical device that received FDA 510(k) clearance on 1991-02-25. The listed applicant is Summit World Trade Corp.. The 510(k) number is K905833.

When did MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY receive FDA 510(k) clearance?

MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY received FDA 510(k) clearance on 1991-02-25, under 510(k) number K905833.

Who is the listed applicant for MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY?

The FDA 510(k) record lists Summit World Trade Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY?

The FDA product code for MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY is LNH.

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Other records listing Summit World Trade Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K905832MRP -5000(1): VERSION 2.0 SOFTWAREK905834MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHYK905835MRP-7000: SUPPLEMENTAL R/F COILSK903318MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30K903203MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTIONK903204MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL

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Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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