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FDA 510(k)

AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE

K-Number: K012154 · 2001-09-19

ApplicantAurora Imaging Technology, Inc.
Decision Date2001-09-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Imaging Technology, Inc.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012154. 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 AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Aurora Imaging Technology, Inc.. The 510(k) number is K012154.

When did AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE receive FDA 510(k) clearance?

AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012154.

Who is the listed applicant for AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

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

What is the FDA product code for AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

The FDA product code for AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE is LNH.

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Other records listing Aurora Imaging Technology, 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.

K073425MODIFICATION TO AURORA MRI SYSTEMK052698MODIFICATION TO: AURORAK032678MODIFICATION TO: AURORAK032082AURORAK023686AURORA MR-GUIDED INTERVENTIONAL SYSTEMK003651AURORA

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Related Devices (Code: LNH)

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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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