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FDA 510(k)

AURORA

K-Number: K003651 · 2001-02-21

ApplicantAurora Imaging Technology, Inc.
Decision Date2001-02-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AURORA 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 2001-02-21 under 510(k) number K003651. 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?

AURORA is a medical device that received FDA 510(k) clearance on 2001-02-21. The listed applicant is Aurora Imaging Technology, Inc.. The 510(k) number is K003651.

When did AURORA receive FDA 510(k) clearance?

AURORA received FDA 510(k) clearance on 2001-02-21, under 510(k) number K003651.

Who is the listed applicant for AURORA?

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?

The FDA product code for AURORA 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 SYSTEMK012154AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE

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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.

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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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