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FDA 510(k)

SV BRAIN ARRAY, SIEMENS 3T

K-Number: K111802 · 2011-09-08

ApplicantMri Interventions, Inc.
Decision Date2011-09-08
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SV BRAIN ARRAY, SIEMENS 3T is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2011-09-08 under 510(k) number K111802. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SV BRAIN ARRAY, SIEMENS 3T?

SV BRAIN ARRAY, SIEMENS 3T is a medical device that received FDA 510(k) clearance on 2011-09-08. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K111802.

When did SV BRAIN ARRAY, SIEMENS 3T receive FDA 510(k) clearance?

SV BRAIN ARRAY, SIEMENS 3T received FDA 510(k) clearance on 2011-09-08, under 510(k) number K111802.

Who is the listed applicant for SV BRAIN ARRAY, SIEMENS 3T?

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

What is the FDA product code for SV BRAIN ARRAY, SIEMENS 3T?

The FDA product code for SV BRAIN ARRAY, SIEMENS 3T is MOS.

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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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