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FDA 510(k)

OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE

K-Number: K973793 · 1997-12-17

ApplicantOlicon Imaging Systems, Inc.
Decision Date1997-12-17
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Olicon Imaging Systems, Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K973793. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE?

OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Olicon Imaging Systems, Inc.. The 510(k) number is K973793.

When did OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE receive FDA 510(k) clearance?

OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE received FDA 510(k) clearance on 1997-12-17, under 510(k) number K973793.

Who is the listed applicant for OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE?

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

What is the FDA product code for OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE?

The FDA product code for OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE is LMD.

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 Olicon Imaging Systems, 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.

K973959OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWAREK922164RAYTEL DIGITAL IMAGING SYSTEMS

Related Devices (Code: LMD)

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.

K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.K992698STENTOR, PAGEVIEWStentor, Inc.K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.

Official Source

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