Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SUPRIA w/guideShot Option

K-Number: K161748 · 2016-08-17

ApplicantHitachi Medical Systems America, Inc.
Decision Date2016-08-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUPRIA w/guideShot Option is a medical device manufactured by Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-08-17 under approval number K161748. 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 SUPRIA w/guideShot Option?

SUPRIA w/guideShot Option is a medical device that received FDA 510(k) clearance on 2016-08-17. It is manufactured by Hitachi Medical Systems America, Inc.. The 510(k) number is K161748.

When was SUPRIA w/guideShot Option approved by the FDA?

SUPRIA w/guideShot Option received FDA 510(k) clearance on 2016-08-17, under approval number K161748.

What company makes SUPRIA w/guideShot Option?

SUPRIA w/guideShot Option is manufactured by Hitachi Medical Systems America, Inc..

What is the FDA product code for SUPRIA w/guideShot Option?

The FDA product code for SUPRIA w/guideShot Option is JAK.

Other Devices by Hitachi Medical Systems America, Inc.

K162079TRILLIUM Oval Head Coil 32 K160152Trillium Oval V 5.1 MRI System K153547ECHELON Oval V 5.1 MRI System K163528HITACHI Supria Whole-body X-ray CT System Phase 3

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161066SpotLight CTArineta , Ltd.

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.

↑