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FDA 510(k)

IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM

K-Number: K870039 · 1987-02-12

ApplicantPar Microsystems Corp.
Decision Date1987-02-12
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Par Microsystems Corp.. It received FDA 510(k) clearance on 1987-02-12 under 510(k) number K870039. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM?

IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1987-02-12. The listed applicant is Par Microsystems Corp.. The 510(k) number is K870039.

When did IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM receive FDA 510(k) clearance?

IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM received FDA 510(k) clearance on 1987-02-12, under 510(k) number K870039.

Who is the listed applicant for IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM?

The FDA 510(k) record lists Par Microsystems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM?

The FDA product code for IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM is DSF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Par Microsystems Corp. 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.

K923435CORNEAL TOPOGRAPHY SYSTEM

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, Inc.

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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