Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND

K-Number: K901658 · 1990-09-04

ApplicantHitachi Medical Corp. of America
Decision Date1990-09-04
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND 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 1990-09-04 under 510(k) number K901658. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND?

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K901658.

When did ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND receive FDA 510(k) clearance?

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND received FDA 510(k) clearance on 1990-09-04, under 510(k) number K901658.

Who is the listed applicant for ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND?

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 ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND?

The FDA product code for ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND is DXK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 32 devices →

Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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.

↑