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FDA 510(k)

ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED

K-Number: K912364 · 1992-08-26

ApplicantHitachi Medical Corp. of America
Decision Date1992-08-26
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp. of America. It received FDA 510(k) clearance on 1992-08-26 under 510(k) number K912364. 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 ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED?

ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED is a medical device that received FDA 510(k) clearance on 1992-08-26. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K912364.

When did ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED receive FDA 510(k) clearance?

ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED received FDA 510(k) clearance on 1992-08-26, under 510(k) number K912364.

Who is the listed applicant for ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED?

The FDA 510(k) record lists Hitachi Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED?

The FDA product code for ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED is ITX.

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Other records listing Hitachi Medical Corp. of America 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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