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)

PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0

K-Number: K122537 · 2013-04-12

ApplicantHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
Decision Date2013-04-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical. It received FDA 510(k) clearance on 2013-04-12 under 510(k) number K122537. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0?

PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 is a medical device that received FDA 510(k) clearance on 2013-04-12. The listed applicant is Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical. The 510(k) number is K122537.

When did PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 receive FDA 510(k) clearance?

PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 received FDA 510(k) clearance on 2013-04-12, under 510(k) number K122537.

Who is the listed applicant for PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0?

The FDA 510(k) record lists Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0?

The FDA product code for PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 is IYN.

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

Related Devices (Code: IYN)

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.

K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)Sonoscape Medical Corp.K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

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.

↑