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FDA 510(k)

SCANVIEW HER2/NEU FISH SYSTEM

K-Number: K101291 · 2010-11-23

ApplicantApplied Spectral Imaging , Ltd.
Decision Date2010-11-23
Product CodeNTH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SCANVIEW HER2/NEU FISH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Spectral Imaging , Ltd.. It received FDA 510(k) clearance on 2010-11-23 under 510(k) number K101291. The device is classified under product code NTH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANVIEW HER2/NEU FISH SYSTEM?

SCANVIEW HER2/NEU FISH SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-23. The listed applicant is Applied Spectral Imaging , Ltd.. The 510(k) number is K101291.

When did SCANVIEW HER2/NEU FISH SYSTEM receive FDA 510(k) clearance?

SCANVIEW HER2/NEU FISH SYSTEM received FDA 510(k) clearance on 2010-11-23, under 510(k) number K101291.

Who is the listed applicant for SCANVIEW HER2/NEU FISH SYSTEM?

The FDA 510(k) record lists Applied Spectral Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCANVIEW HER2/NEU FISH SYSTEM?

The FDA product code for SCANVIEW HER2/NEU FISH SYSTEM is NTH.

Related Clinical Trials

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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Other records listing Applied Spectral Imaging , Ltd. 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.

K122554GENASIS SCANVIEW SYSTEMK071398SCANVIEW, MODEL SC-300K050236FISHVIEWK012103BANDVIEW SYSTEMK973950RETINAL CUBE

Related Devices (Code: NTH)

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.

K122554GENASIS SCANVIEW SYSTEMApplied Spectral Imaging , Ltd.K110345SCANVIEW SYSTEMApplied Spectral ImagingK080909ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000Ikonisys, Inc.K043519ARIOL HER-2/NEU FISHApplied Imaging Corp.K042542CYTOVISION FOR CEP XYApplied Imaging Corp.

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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