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FDA 510(k)

GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE

K-Number: K890789 · 1989-04-28

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1989-04-28
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1989-04-28 under 510(k) number K890789. 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 GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE is a medical device that received FDA 510(k) clearance on 1989-04-28. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K890789.

When did GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE receive FDA 510(k) clearance?

GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE received FDA 510(k) clearance on 1989-04-28, under 510(k) number K890789.

Who is the listed applicant for GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

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

What is the FDA product code for GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

The FDA product code for GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE is LNH.

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Other records listing Philips Medical Systems North 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.

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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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