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FDA 510(k)

IDS4 IMAGE DISPLAY SYSTEM SERIES

K-Number: K971368 · 1997-06-26

ApplicantO Tech, Inc.
Decision Date1997-06-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IDS4 IMAGE DISPLAY SYSTEM SERIES 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 1997-06-26 under 510(k) number K971368. 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 IMAGE DISPLAY SYSTEM SERIES?

IDS4 IMAGE DISPLAY SYSTEM SERIES is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is O Tech, Inc.. The 510(k) number is K971368.

When did IDS4 IMAGE DISPLAY SYSTEM SERIES receive FDA 510(k) clearance?

IDS4 IMAGE DISPLAY SYSTEM SERIES received FDA 510(k) clearance on 1997-06-26, under 510(k) number K971368.

Who is the listed applicant for IDS4 IMAGE DISPLAY SYSTEM SERIES?

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 IMAGE DISPLAY SYSTEM SERIES?

The FDA product code for IDS4 IMAGE DISPLAY SYSTEM SERIES 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.

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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.

K991643IDS4 V3.2 IMAGE DISPLAY SYSTEMK973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEK971451WISE IMAGE MANAGEMENT SYSTEM

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

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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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