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FDA 510(k)

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS

K-Number: K003453 · 2001-01-18

ApplicantFonar Corp.
Decision Date2001-01-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS is the device name listed in this FDA 510(k) record. The listed applicant is Fonar Corp.. It received FDA 510(k) clearance on 2001-01-18 under 510(k) number K003453. 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 SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS?

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS is a medical device that received FDA 510(k) clearance on 2001-01-18. The listed applicant is Fonar Corp.. The 510(k) number is K003453.

When did SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS receive FDA 510(k) clearance?

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS received FDA 510(k) clearance on 2001-01-18, under 510(k) number K003453.

Who is the listed applicant for SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS?

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

What is the FDA product code for SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS?

The FDA product code for SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS is LNH.

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Other records listing Fonar 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.

K061930INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORYK011485PINNACLE MAGNETIC RESONANCE IMAGING SCANNERK002490INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNERK994287FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNERK951681QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNERK940772ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)

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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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