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FDA 510(k)

BANDVIEW SYSTEM

K-Number: K012103 · 2001-09-14

ApplicantApplied Spectral Imaging , Ltd.
Decision Date2001-09-14
Product CodeLNJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BANDVIEW 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 2001-09-14 under 510(k) number K012103. The device is classified under product code LNJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BANDVIEW SYSTEM?

BANDVIEW SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-14. The listed applicant is Applied Spectral Imaging , Ltd.. The 510(k) number is K012103.

When did BANDVIEW SYSTEM receive FDA 510(k) clearance?

BANDVIEW SYSTEM received FDA 510(k) clearance on 2001-09-14, under 510(k) number K012103.

Who is the listed applicant for BANDVIEW 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 BANDVIEW SYSTEM?

The FDA product code for BANDVIEW SYSTEM is LNJ.

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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 SYSTEMK101291SCANVIEW HER2/NEU FISH SYSTEMK071398SCANVIEW, MODEL SC-300K050236FISHVIEWK973950RETINAL CUBE

Related Devices (Code: LNJ)

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.

K050236FISHVIEWApplied Spectral Imaging , Ltd.K940240IKAROSMetasystems GmbHK912085ACLAIMS-ISW-TechnologyK902311GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.Applied Imaging Corp.K895095AKS IIAmoco Technology Co.K872755KARYOTEC 100Amcor Electronics, Ltd.

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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