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FDA 510(k)

ACUSON L538 TRANSDUCER

K-Number: K893863 · 1990-05-23

ApplicantAcuson Computed Sonography
Decision Date1990-05-23
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON L538 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 1990-05-23 under 510(k) number K893863. 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 L538 TRANSDUCER?

ACUSON L538 TRANSDUCER is a medical device that received FDA 510(k) clearance on 1990-05-23. The listed applicant is Acuson Computed Sonography. The 510(k) number is K893863.

When did ACUSON L538 TRANSDUCER receive FDA 510(k) clearance?

ACUSON L538 TRANSDUCER received FDA 510(k) clearance on 1990-05-23, under 510(k) number K893863.

Who is the listed applicant for ACUSON L538 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 L538 TRANSDUCER?

The FDA product code for ACUSON L538 TRANSDUCER 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.

K874028ACUSON 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.K871506ACUSON L538 TRANSDUCER

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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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