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FDA 510(k)

LCA ANGIOGRAPHIC IMAGING SYSTEM

K-Number: K941946 · 1994-05-20

ApplicantGE Medical Systems
Decision Date1994-05-20
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LCA ANGIOGRAPHIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1994-05-20 under 510(k) number K941946. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LCA ANGIOGRAPHIC IMAGING SYSTEM?

LCA ANGIOGRAPHIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-05-20. The listed applicant is GE Medical Systems. The 510(k) number is K941946.

When did LCA ANGIOGRAPHIC IMAGING SYSTEM receive FDA 510(k) clearance?

LCA ANGIOGRAPHIC IMAGING SYSTEM received FDA 510(k) clearance on 1994-05-20, under 510(k) number K941946.

Who is the listed applicant for LCA ANGIOGRAPHIC IMAGING SYSTEM?

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

What is the FDA product code for LCA ANGIOGRAPHIC IMAGING SYSTEM?

The FDA product code for LCA ANGIOGRAPHIC IMAGING SYSTEM is IZI.

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Other records listing GE Medical Systems 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.

K253808AIR Recon DLK220848Venue FitK220851VenueK173341Vivid E80, Vivid E90, Vivid E95K103411IDEAL IQ SOFTWARE OPTIONK073138CARDIQ EXPRESS VERSION 2.0

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Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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