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FDA 510(k)

EUB-515 DIAGNOSTIC ULTRASOUND DEVICE

K-Number: K897042 · 1990-09-13

ApplicantHitachi Medical Corp. of America
Decision Date1990-09-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EUB-515 DIAGNOSTIC ULTRASOUND DEVICE 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 1990-09-13 under 510(k) number K897042. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUB-515 DIAGNOSTIC ULTRASOUND DEVICE?

EUB-515 DIAGNOSTIC ULTRASOUND DEVICE is a medical device that received FDA 510(k) clearance on 1990-09-13. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K897042.

When did EUB-515 DIAGNOSTIC ULTRASOUND DEVICE receive FDA 510(k) clearance?

EUB-515 DIAGNOSTIC ULTRASOUND DEVICE received FDA 510(k) clearance on 1990-09-13, under 510(k) number K897042.

Who is the listed applicant for EUB-515 DIAGNOSTIC ULTRASOUND DEVICE?

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 EUB-515 DIAGNOSTIC ULTRASOUND DEVICE?

The FDA product code for EUB-515 DIAGNOSTIC ULTRASOUND DEVICE is IYO.

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Other records listing Hitachi Medical Corp. of America 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.

K994026EUB-6000 ULTRASOUND DIAGNOSTIC SCANNERK991535CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERASK991318CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERASK991129HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTALK981434EUP-OL334 LAPARASCOPICPROBEK954220EUB-8000

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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