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FDA 510(k)

NEURO II-S

K-Number: K050132 · 2005-02-15

ApplicantInnovative Magnetic Resonance Imaging Systems, Inc.
Decision Date2005-02-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEURO II-S is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Magnetic Resonance Imaging Systems, Inc.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K050132. 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 NEURO II-S?

NEURO II-S is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Innovative Magnetic Resonance Imaging Systems, Inc.. The 510(k) number is K050132.

When did NEURO II-S receive FDA 510(k) clearance?

NEURO II-S received FDA 510(k) clearance on 2005-02-15, under 510(k) number K050132.

Who is the listed applicant for NEURO II-S?

The FDA 510(k) record lists Innovative Magnetic Resonance Imaging Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEURO II-S?

The FDA product code for NEURO II-S 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.

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Other records listing Innovative Magnetic Resonance Imaging Systems, 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.

K002964NEURO II

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.

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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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