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FDA 510(k)

ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER

K-Number: K974544 · 1998-03-18

ApplicantAloka Co., Ltd.
Decision Date1998-03-18
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Aloka Co., Ltd.. It received FDA 510(k) clearance on 1998-03-18 under 510(k) number K974544. 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 ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER?

ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER is a medical device that received FDA 510(k) clearance on 1998-03-18. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K974544.

When did ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER receive FDA 510(k) clearance?

ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER received FDA 510(k) clearance on 1998-03-18, under 510(k) number K974544.

Who is the listed applicant for ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER?

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

What is the FDA product code for ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER?

The FDA product code for ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER is ITX.

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Other records listing Aloka Co., Ltd. as applicant

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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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