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FDA 510(k)

SINVISION LINEAR ARRAY REAL TIME

K-Number: K800653 · 1980-07-21

ApplicantKt Medical, Inc.
Decision Date1980-07-21
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SINVISION LINEAR ARRAY REAL TIME is the device name listed in this FDA 510(k) record. The listed applicant is Kt Medical, Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K800653. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINVISION LINEAR ARRAY REAL TIME?

SINVISION LINEAR ARRAY REAL TIME is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Kt Medical, Inc.. The 510(k) number is K800653.

When did SINVISION LINEAR ARRAY REAL TIME receive FDA 510(k) clearance?

SINVISION LINEAR ARRAY REAL TIME received FDA 510(k) clearance on 1980-07-21, under 510(k) number K800653.

Who is the listed applicant for SINVISION LINEAR ARRAY REAL TIME?

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

What is the FDA product code for SINVISION LINEAR ARRAY REAL TIME?

The FDA product code for SINVISION LINEAR ARRAY REAL TIME is DXK.

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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 Kt Medical, 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.

K800652MODEL E03 ECHO-OPTHALMOSCOPEK8001014200 ME ECHOENCEPHALOGRAPHK800092COMBISON COMPUTERK800099INTRACULA IIK8001007200 MA ECHO-OPHTHALMOSCOPEK800093TRANSDUCER

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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