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FDA 510(k)

EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER

K-Number: K862164 · 1986-11-04

ApplicantHitachi Medical Corp. of America
Decision Date1986-11-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent for Some Indications

Device Summary

EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER 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 1986-11-04 under 510(k) number K862164. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER?

EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER is a medical device that received FDA 510(k) clearance on 1986-11-04. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K862164.

When did EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER receive FDA 510(k) clearance?

EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER received FDA 510(k) clearance on 1986-11-04, under 510(k) number K862164.

Who is the listed applicant for EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER?

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 EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER?

The FDA product code for EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER 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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