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FDA 510(k)

ECHELON SPECTROSCOPY PACKAGE

K-Number: K071506 · 2007-06-28

ApplicantHitachi Medical Systems America, Inc.
Decision Date2007-06-28
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHELON SPECTROSCOPY PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2007-06-28 under 510(k) number K071506. 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 ECHELON SPECTROSCOPY PACKAGE?

ECHELON SPECTROSCOPY PACKAGE is a medical device that received FDA 510(k) clearance on 2007-06-28. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K071506.

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

ECHELON SPECTROSCOPY PACKAGE received FDA 510(k) clearance on 2007-06-28, under 510(k) number K071506.

Who is the listed applicant for ECHELON SPECTROSCOPY PACKAGE?

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

What is the FDA product code for ECHELON SPECTROSCOPY PACKAGE?

The FDA product code for ECHELON SPECTROSCOPY PACKAGE is LNI.

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Other records listing Hitachi Medical Systems 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.

K163528HITACHI Supria Whole-body X-ray CT System Phase 3K162079TRILLIUM Oval Head Coil 32K161748SUPRIA w/guideShot OptionK160152Trillium Oval V 5.1 MRI SystemK153547ECHELON Oval V 5.1 MRI SystemK123509SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

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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.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 SystemsK991568MR SPECTROSCOPY PACKAGEPhilips Medical Systems (Cleveland), Inc.K984167SAGE 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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