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FDA 510(k)

LASER IMAGING WORK STATION

K-Number: K897186 · 1990-03-12

ApplicantInnovision Medical, Inc.
Decision Date1990-03-12
Product CodeHJI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LASER IMAGING WORK STATION is the device name listed in this FDA 510(k) record. The listed applicant is Innovision Medical, Inc.. It received FDA 510(k) clearance on 1990-03-12 under 510(k) number K897186. The device is classified under product code HJI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER IMAGING WORK STATION?

LASER IMAGING WORK STATION is a medical device that received FDA 510(k) clearance on 1990-03-12. The listed applicant is Innovision Medical, Inc.. The 510(k) number is K897186.

When did LASER IMAGING WORK STATION receive FDA 510(k) clearance?

LASER IMAGING WORK STATION received FDA 510(k) clearance on 1990-03-12, under 510(k) number K897186.

Who is the listed applicant for LASER IMAGING WORK STATION?

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

What is the FDA product code for LASER IMAGING WORK STATION?

The FDA product code for LASER IMAGING WORK STATION is HJI.

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 Innovision Medical, 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.

K890133OCULAR CONNECTION MACHINE(TM)

Related Devices (Code: HJI)

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.

K923670BYRNE EXPULSIVE LENSOcular Instruments, Inc.K902138STRIPE PROJECTORAcademic Catalyst Corp.K90183960 FUNDUS CAMERA CF-60UVCanon USA, Inc.K820223OMS QUARTZ INFUSION CONTACT LENSOptical Micro Systems, Inc.K802971LANDERS CONTACT LENSCooper Medical Devices Corp.K802927SEBESTYEN IRRIGATING CONTACT LENSCooper Medical Devices Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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