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)

FAST SPIN ECHO (FSE)

K-Number: K935369 · 1994-03-21

ApplicantResonex, Inc.
Decision Date1994-03-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FAST SPIN ECHO (FSE) is the device name listed in this FDA 510(k) record. The listed applicant is Resonex, Inc.. It received FDA 510(k) clearance on 1994-03-21 under 510(k) number K935369. 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 FAST SPIN ECHO (FSE)?

FAST SPIN ECHO (FSE) is a medical device that received FDA 510(k) clearance on 1994-03-21. The listed applicant is Resonex, Inc.. The 510(k) number is K935369.

When did FAST SPIN ECHO (FSE) receive FDA 510(k) clearance?

FAST SPIN ECHO (FSE) received FDA 510(k) clearance on 1994-03-21, under 510(k) number K935369.

Who is the listed applicant for FAST SPIN ECHO (FSE)?

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

What is the FDA product code for FAST SPIN ECHO (FSE)?

The FDA product code for FAST SPIN ECHO (FSE) is LNH.

Other records listing Resonex, Inc. 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.

K935570NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEMK931392ECG GATING UNITK9238703DTOF MRAK924154KINEMATIC MRI MOVIEMAKERK9238233D IMAGINGK922677MAGNETIZATION TRANSFER CONTRAST

View all 21 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.

↑