FDA 510(k)

PRONTO

K-Number: K014240 · 2002-03-22

ApplicantHitachi Medical Systems America, Inc.

Decision Date2002-03-22

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PRONTO is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2002-03-22 under 510(k) number K014240. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRONTO?

PRONTO is a medical device that received FDA 510(k) clearance on 2002-03-22. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K014240.

When did PRONTO receive FDA 510(k) clearance?

PRONTO received FDA 510(k) clearance on 2002-03-22, under 510(k) number K014240.

Who is the listed applicant for PRONTO?

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

What is the FDA product code for PRONTO?

The FDA product code for PRONTO is JAK.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hitachi Medical Systems America, Inc. as applicant

K163528HITACHI Supria Whole-body X-ray CT System Phase 3 K162079TRILLIUM Oval Head Coil 32 K161748SUPRIA w/guideShot Option K160152Trillium Oval V 5.1 MRI System K153547ECHELON Oval V 5.1 MRI System K123509SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

View all 95 devices →

Related Devices (Code: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, 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.