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FDA 510(k)

EUB-555A+

K-Number: K945795 · 1995-10-27

ApplicantHitachi Medical Corp. of America
Decision Date1995-10-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EUB-555A+ 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 1995-10-27 under 510(k) number K945795. 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-555A+?

EUB-555A+ is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K945795.

When did EUB-555A+ receive FDA 510(k) clearance?

EUB-555A+ received FDA 510(k) clearance on 1995-10-27, under 510(k) number K945795.

Who is the listed applicant for EUB-555A+?

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-555A+?

The FDA product code for EUB-555A+ is IYO.

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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