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FDA 510(k)

WISE IMAGE MANAGEMENT SYSTEM

K-Number: K971451 · 1997-06-26

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

Device Summary

WISE IMAGE MANAGEMENT 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 1997-06-26 under 510(k) number K971451. 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 WISE IMAGE MANAGEMENT SYSTEM?

WISE IMAGE MANAGEMENT SYSTEM 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 K971451.

When did WISE IMAGE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

WISE IMAGE MANAGEMENT SYSTEM received FDA 510(k) clearance on 1997-06-26, under 510(k) number K971451.

Who is the listed applicant for WISE IMAGE MANAGEMENT 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 WISE IMAGE MANAGEMENT SYSTEM?

The FDA product code for WISE IMAGE MANAGEMENT SYSTEM 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.

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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, ARCHIVEK971368IDS4 IMAGE DISPLAY SYSTEM SERIES

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

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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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