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FDA 510(k)

CINE'VIEW - STRESS ECHO & IMAGE REVIEW

K-Number: K904976 · 1991-02-25

ApplicantPrism Imaging, Inc.
Decision Date1991-02-25
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CINE'VIEW - STRESS ECHO & IMAGE REVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Prism Imaging, Inc.. It received FDA 510(k) clearance on 1991-02-25 under 510(k) number K904976. 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 CINE'VIEW - STRESS ECHO & IMAGE REVIEW?

CINE'VIEW - STRESS ECHO & IMAGE REVIEW is a medical device that received FDA 510(k) clearance on 1991-02-25. The listed applicant is Prism Imaging, Inc.. The 510(k) number is K904976.

When did CINE'VIEW - STRESS ECHO & IMAGE REVIEW receive FDA 510(k) clearance?

CINE'VIEW - STRESS ECHO & IMAGE REVIEW received FDA 510(k) clearance on 1991-02-25, under 510(k) number K904976.

Who is the listed applicant for CINE'VIEW - STRESS ECHO & IMAGE REVIEW?

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

What is the FDA product code for CINE'VIEW - STRESS ECHO & IMAGE REVIEW?

The FDA product code for CINE'VIEW - STRESS ECHO & IMAGE REVIEW is DXK.

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Other records listing Prism Imaging, 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.

K904975VISTA VIEWING STATIONK904977CINE/VIEW PLUS - CARDIOLOGY WORKSTATIONK904978SOFTWARE PROGRAM USED W/PRISM PRODUCTS

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

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