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FDA 510(k)

ULTRASOUND SCANNER XL

K-Number: K834307 · 1984-02-21

ApplicantInterad Systems, Inc.
Decision Date1984-02-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER XL is the device name listed in this FDA 510(k) record. The listed applicant is Interad Systems, Inc.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K834307. 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 ULTRASOUND SCANNER XL?

ULTRASOUND SCANNER XL is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Interad Systems, Inc.. The 510(k) number is K834307.

When did ULTRASOUND SCANNER XL receive FDA 510(k) clearance?

ULTRASOUND SCANNER XL received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834307.

Who is the listed applicant for ULTRASOUND SCANNER XL?

The FDA 510(k) record lists Interad Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND SCANNER XL?

The FDA product code for ULTRASOUND SCANNER XL 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 Interad Systems, Inc. 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.

K834087MODEL XLEK833821INTERAD 520K813162INTERAD WHOLE BODY CT SCANNER

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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