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FDA 510(k)

CYTOSCAN

K-Number: K864955 · 1987-03-16

ApplicantImage Recognition Systems , Ltd.
Decision Date1987-03-16
Product CodeLNJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CYTOSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Image Recognition Systems , Ltd.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K864955. 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 CYTOSCAN?

CYTOSCAN is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Image Recognition Systems , Ltd.. The 510(k) number is K864955.

When did CYTOSCAN receive FDA 510(k) clearance?

CYTOSCAN received FDA 510(k) clearance on 1987-03-16, under 510(k) number K864955.

Who is the listed applicant for CYTOSCAN?

The FDA 510(k) record lists Image Recognition Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYTOSCAN?

The FDA product code for CYTOSCAN is LNJ.

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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.K012103BANDVIEW SYSTEMApplied Spectral Imaging , Ltd.K940240IKAROSMetasystems GmbHK912085ACLAIMS-ISW-TechnologyK902311GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.Applied Imaging Corp.K895095AKS IIAmoco Technology Co.

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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