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)

HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS

K-Number: K022928 · 2002-12-11

ApplicantHudson Diagnostic Imaging, LLC
Decision Date2002-12-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Diagnostic Imaging, LLC. It received FDA 510(k) clearance on 2002-12-11 under 510(k) number K022928. 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 HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS?

HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS is a medical device that received FDA 510(k) clearance on 2002-12-11. The listed applicant is Hudson Diagnostic Imaging, LLC. The 510(k) number is K022928.

When did HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS receive FDA 510(k) clearance?

HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS received FDA 510(k) clearance on 2002-12-11, under 510(k) number K022928.

Who is the listed applicant for HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS?

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

What is the FDA product code for HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS?

The FDA product code for HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS is IYO.

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 Hudson Diagnostic Imaging, LLC 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.

K040926ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000

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.

↑