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FDA 510(k)

RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER

K-Number: K883845 · 1989-02-03

ApplicantPhoenix Imaging
Decision Date1989-02-03
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Imaging. It received FDA 510(k) clearance on 1989-02-03 under 510(k) number K883845. 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 RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER?

RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Phoenix Imaging. The 510(k) number is K883845.

When did RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER receive FDA 510(k) clearance?

RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER received FDA 510(k) clearance on 1989-02-03, under 510(k) number K883845.

Who is the listed applicant for RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER?

The FDA 510(k) record lists Phoenix Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER?

The FDA product code for RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER 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 Phoenix Imaging 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.

K880839AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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