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FDA 510(k)

MODEL SSH-140A ULTRASOUND IMAGING SYSTEM

K-Number: K894632 · 1989-10-19

ApplicantToshiba America Medical Systems, In.C
Decision Date1989-10-19
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SSH-140A ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K894632. 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 MODEL SSH-140A ULTRASOUND IMAGING SYSTEM?

MODEL SSH-140A ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K894632.

When did MODEL SSH-140A ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

MODEL SSH-140A ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1989-10-19, under 510(k) number K894632.

Who is the listed applicant for MODEL SSH-140A ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL SSH-140A ULTRASOUND IMAGING SYSTEM?

The FDA product code for MODEL SSH-140A ULTRASOUND IMAGING SYSTEM is DXK.

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Other records listing Toshiba America Medical Systems, In.C 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.

K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREK131822ULTRAEXTEND USWS-900A V2.1 AND V3.1K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USK122842RADREX-I, SW V4.00 MODEL DRAD-3000EK121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE

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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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