Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OPD-STATION SOFTWARE

K-Number: K050336 · 2005-08-24

ApplicantNidek, Inc.
Decision Date2005-08-24
Product CodeNCF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPD-STATION SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 2005-08-24 under 510(k) number K050336. The device is classified under product code NCF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPD-STATION SOFTWARE?

OPD-STATION SOFTWARE is a medical device that received FDA 510(k) clearance on 2005-08-24. The listed applicant is Nidek, Inc.. The 510(k) number is K050336.

When did OPD-STATION SOFTWARE receive FDA 510(k) clearance?

OPD-STATION SOFTWARE received FDA 510(k) clearance on 2005-08-24, under 510(k) number K050336.

Who is the listed applicant for OPD-STATION SOFTWARE?

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

What is the FDA product code for OPD-STATION SOFTWARE?

The FDA product code for OPD-STATION SOFTWARE is NCF.

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 Nidek, 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.

K042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800K014274NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000

View all 77 devices →

Related Devices (Code: NCF)

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.

K062930LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEMAlcon Research, Ltd.K023249ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEMAlcon Laboratories, Inc.K000637CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)Alcon Laboratories, Inc.

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.

↑