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FDA 510(k)

VISTA VIEWING STATION

K-Number: K904975 · 1991-02-25

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

Device Summary

VISTA VIEWING STATION 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 K904975. 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 VISTA VIEWING STATION?

VISTA VIEWING STATION 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 K904975.

When did VISTA VIEWING STATION receive FDA 510(k) clearance?

VISTA VIEWING STATION received FDA 510(k) clearance on 1991-02-25, under 510(k) number K904975.

Who is the listed applicant for VISTA VIEWING STATION?

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 VISTA VIEWING STATION?

The FDA product code for VISTA VIEWING STATION is DXK.

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 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.

K904977CINE/VIEW PLUS - CARDIOLOGY WORKSTATIONK904976CINE'VIEW - STRESS ECHO & IMAGE REVIEWK904978SOFTWARE 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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