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FDA 510(k)

IDS4 V3.2 IMAGE DISPLAY SYSTEM

K-Number: K991643 · 1999-06-08

ApplicantO Tech, Inc.
Decision Date1999-06-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IDS4 V3.2 IMAGE DISPLAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is O Tech, Inc.. It received FDA 510(k) clearance on 1999-06-08 under 510(k) number K991643. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDS4 V3.2 IMAGE DISPLAY SYSTEM?

IDS4 V3.2 IMAGE DISPLAY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-08. The listed applicant is O Tech, Inc.. The 510(k) number is K991643.

When did IDS4 V3.2 IMAGE DISPLAY SYSTEM receive FDA 510(k) clearance?

IDS4 V3.2 IMAGE DISPLAY SYSTEM received FDA 510(k) clearance on 1999-06-08, under 510(k) number K991643.

Who is the listed applicant for IDS4 V3.2 IMAGE DISPLAY SYSTEM?

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

What is the FDA product code for IDS4 V3.2 IMAGE DISPLAY SYSTEM?

The FDA product code for IDS4 V3.2 IMAGE DISPLAY SYSTEM is LLZ.

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 O Tech, 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.

K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEK971451WISE IMAGE MANAGEMENT SYSTEMK971368IDS4 IMAGE DISPLAY SYSTEM SERIES

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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