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FDA 510(k)

ACUSON S319 TRANSDUCER

K-Number: K862159 · 1986-07-24

ApplicantAcuson Computed Sonography
Decision Date1986-07-24
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUSON S319 TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Computed Sonography. It received FDA 510(k) clearance on 1986-07-24 under 510(k) number K862159. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON S319 TRANSDUCER?

ACUSON S319 TRANSDUCER is a medical device that received FDA 510(k) clearance on 1986-07-24. The listed applicant is Acuson Computed Sonography. The 510(k) number is K862159.

When did ACUSON S319 TRANSDUCER receive FDA 510(k) clearance?

ACUSON S319 TRANSDUCER received FDA 510(k) clearance on 1986-07-24, under 510(k) number K862159.

Who is the listed applicant for ACUSON S319 TRANSDUCER?

The FDA 510(k) record lists Acuson Computed Sonography as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON S319 TRANSDUCER?

The FDA product code for ACUSON S319 TRANSDUCER is JOP.

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Other records listing Acuson Computed Sonography 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.

K893863ACUSON L538 TRANSDUCERK874028ACUSON S328 TRANSDUCERK874861ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.K874363ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.K874922ACUSON TRANSPERINEAL NEEDLE GUIDEK874860ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.

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Related Devices (Code: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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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