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FDA 510(k)

ECHOSTAR SPICA 1.5T MR SYSTEM

K-Number: K113511 · 2012-05-02

ApplicantAlltech Medical Systems America, Inc.
Decision Date2012-05-02
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHOSTAR SPICA 1.5T MR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alltech Medical Systems America, Inc.. It received FDA 510(k) clearance on 2012-05-02 under 510(k) number K113511. 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 ECHOSTAR SPICA 1.5T MR SYSTEM?

ECHOSTAR SPICA 1.5T MR SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-02. The listed applicant is Alltech Medical Systems America, Inc.. The 510(k) number is K113511.

When did ECHOSTAR SPICA 1.5T MR SYSTEM receive FDA 510(k) clearance?

ECHOSTAR SPICA 1.5T MR SYSTEM received FDA 510(k) clearance on 2012-05-02, under 510(k) number K113511.

Who is the listed applicant for ECHOSTAR SPICA 1.5T MR SYSTEM?

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

What is the FDA product code for ECHOSTAR SPICA 1.5T MR SYSTEM?

The FDA product code for ECHOSTAR SPICA 1.5T MR SYSTEM is LNH.

Related Clinical Trials

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Other records listing Alltech Medical Systems America, 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.

K163192Comfort EC710K082100ALLTECH ECHOSTAR 1.5 T MR SYSTEM

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.

K261283APERTO Lucent MRI SystemFujifilm CorporationK261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K260758MAGNETOM 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

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

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