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FDA 510(k)

SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM

K-Number: K932244 · 1994-02-18

ApplicantShimadzu Medical Systems
Decision Date1994-02-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1994-02-18 under 510(k) number K932244. 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 SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM?

SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K932244.

When did SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM receive FDA 510(k) clearance?

SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM received FDA 510(k) clearance on 1994-02-18, under 510(k) number K932244.

Who is the listed applicant for SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM?

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

What is the FDA product code for SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM?

The FDA product code for SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM is LNH.

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Other records listing Shimadzu Medical Systems 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.

K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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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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