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FDA 510(k)

OLYMPUS IMAGEMANAGERSYSTEM

K-Number: K934888 · 1994-01-25

ApplicantOlympus
Decision Date1994-01-25
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLYMPUS IMAGEMANAGERSYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K934888. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS IMAGEMANAGERSYSTEM?

OLYMPUS IMAGEMANAGERSYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Olympus. The 510(k) number is K934888.

When did OLYMPUS IMAGEMANAGERSYSTEM receive FDA 510(k) clearance?

OLYMPUS IMAGEMANAGERSYSTEM received FDA 510(k) clearance on 1994-01-25, under 510(k) number K934888.

Who is the listed applicant for OLYMPUS IMAGEMANAGERSYSTEM?

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

What is the FDA product code for OLYMPUS IMAGEMANAGERSYSTEM?

The FDA product code for OLYMPUS IMAGEMANAGERSYSTEM is LMB.

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 Olympus 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.

K934889OLYMPUS IMAGEMANAGER SYSTEM

Related Devices (Code: LMB)

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.

K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec ABK980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, 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.

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