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FDA 510(k)

QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM

K-Number: K904019 · 1991-03-22

ApplicantQuantum Medical Systems, Inc.
Decision Date1991-03-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-03-22 under 510(k) number K904019. 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 QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM?

QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1991-03-22. The listed applicant is Quantum Medical Systems, Inc.. The 510(k) number is K904019.

When did QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM receive FDA 510(k) clearance?

QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM received FDA 510(k) clearance on 1991-03-22, under 510(k) number K904019.

Who is the listed applicant for QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM?

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

What is the FDA product code for QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM?

The FDA product code for QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM 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 Quantum Medical 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.

K894992QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEMK890998QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.K860581QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEMK853217QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES

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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