FDA 510(k)

HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)

K-Number: K964990 · 1997-02-26

ApplicantHitachi Medical Systems America, Inc.

Decision Date1997-02-26

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) 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 1997-02-26 under 510(k) number K964990. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)?

HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K964990.

When did HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) receive FDA 510(k) clearance?

HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) received FDA 510(k) clearance on 1997-02-26, under 510(k) number K964990.

Who is the listed applicant for HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)?

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 HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)?

The FDA product code for HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) is JAA.

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: JAA)

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC K242488Soteria E-ViewOmega Medical Imaging, LLC K242948Adora DRFi (04550010)Nrt X-Ray A/S K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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.