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)

QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES

K-Number: K853217 · 1985-12-30

ApplicantQuantum Medical Systems, Inc.
Decision Date1985-12-30
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES 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 1985-12-30 under 510(k) number K853217. 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 QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES?

QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Quantum Medical Systems, Inc.. The 510(k) number is K853217.

When did QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES receive FDA 510(k) clearance?

QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES received FDA 510(k) clearance on 1985-12-30, under 510(k) number K853217.

Who is the listed applicant for QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES?

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 QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES?

The FDA product code for QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES 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.

K904019QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEMK894992QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEMK890998QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.K860581QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM

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.

↑