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FDA 510(k)

750 SD ULTRASOUND SCANNER(MODIFICATION)

K-Number: K851901 · 1985-10-23

ApplicantUltrasonix, Inc.
Decision Date1985-10-23
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

750 SD ULTRASOUND SCANNER(MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasonix, Inc.. It received FDA 510(k) clearance on 1985-10-23 under 510(k) number K851901. 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 750 SD ULTRASOUND SCANNER(MODIFICATION)?

750 SD ULTRASOUND SCANNER(MODIFICATION) is a medical device that received FDA 510(k) clearance on 1985-10-23. The listed applicant is Ultrasonix, Inc.. The 510(k) number is K851901.

When did 750 SD ULTRASOUND SCANNER(MODIFICATION) receive FDA 510(k) clearance?

750 SD ULTRASOUND SCANNER(MODIFICATION) received FDA 510(k) clearance on 1985-10-23, under 510(k) number K851901.

Who is the listed applicant for 750 SD ULTRASOUND SCANNER(MODIFICATION)?

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

What is the FDA product code for 750 SD ULTRASOUND SCANNER(MODIFICATION)?

The FDA product code for 750 SD ULTRASOUND SCANNER(MODIFICATION) 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 Ultrasonix, 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.

K871727MODIFIED RADIUS - MODEL NUMBER MM 5000

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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