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FDA 510(k)

ACUSON NEEDLE GUIDE SYSTEM

K-Number: K854429 · 1986-02-07

ApplicantAcuson Computed Sonography
Decision Date1986-02-07
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON NEEDLE GUIDE SYSTEM 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 1986-02-07 under 510(k) number K854429. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON NEEDLE GUIDE SYSTEM?

ACUSON NEEDLE GUIDE SYSTEM is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is Acuson Computed Sonography. The 510(k) number is K854429.

When did ACUSON NEEDLE GUIDE SYSTEM receive FDA 510(k) clearance?

ACUSON NEEDLE GUIDE SYSTEM received FDA 510(k) clearance on 1986-02-07, under 510(k) number K854429.

Who is the listed applicant for ACUSON NEEDLE GUIDE SYSTEM?

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 NEEDLE GUIDE SYSTEM?

The FDA product code for ACUSON NEEDLE GUIDE SYSTEM is ITX.

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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: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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