Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PINNACLE MAGNETIC RESONANCE IMAGING SCANNER

K-Number: K011485 · 2001-06-06

ApplicantFonar Corp.
Decision Date2001-06-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PINNACLE MAGNETIC RESONANCE IMAGING SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Fonar Corp.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K011485. 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 PINNACLE MAGNETIC RESONANCE IMAGING SCANNER?

PINNACLE MAGNETIC RESONANCE IMAGING SCANNER is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Fonar Corp.. The 510(k) number is K011485.

When did PINNACLE MAGNETIC RESONANCE IMAGING SCANNER receive FDA 510(k) clearance?

PINNACLE MAGNETIC RESONANCE IMAGING SCANNER received FDA 510(k) clearance on 2001-06-06, under 510(k) number K011485.

Who is the listed applicant for PINNACLE MAGNETIC RESONANCE IMAGING SCANNER?

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 PINNACLE MAGNETIC RESONANCE IMAGING SCANNER?

The FDA product code for PINNACLE MAGNETIC RESONANCE IMAGING SCANNER is LNH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ACCESSORYK003453SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERSK002490INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNERK994287FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNERK951681QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNERK940772ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)

View all 12 devices →

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.

↑