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FDA 510(k)

MR SPECTROSCOPY PACKAGE

K-Number: K991568 · 1999-07-19

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1999-07-19
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MR SPECTROSCOPY PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1999-07-19 under 510(k) number K991568. The device is classified under product code LNI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR SPECTROSCOPY PACKAGE?

MR SPECTROSCOPY PACKAGE is a medical device that received FDA 510(k) clearance on 1999-07-19. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K991568.

When did MR SPECTROSCOPY PACKAGE receive FDA 510(k) clearance?

MR SPECTROSCOPY PACKAGE received FDA 510(k) clearance on 1999-07-19, under 510(k) number K991568.

Who is the listed applicant for MR SPECTROSCOPY PACKAGE?

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

What is the FDA product code for MR SPECTROSCOPY PACKAGE?

The FDA product code for MR SPECTROSCOPY PACKAGE is LNI.

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Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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Related Devices (Code: LNI)

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.

K093044OASIS MRI SYSTEMHitachi Medical Systems America, Inc.K071506ECHELON SPECTROSCOPY PACKAGEHitachi Medical Systems America, Inc.K011604PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRIGe Medical Systems, Inc.K010129EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3Toshiba America Medical Systems, In.CK003575MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEMGE Medical SystemsK984167SAGE 7GE Medical Systems

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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