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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 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 2016-08-17 under 510(k) 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. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K161748.

When did SUPRIA w/guideShot Option receive FDA 510(k) clearance?

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

Who is the listed applicant for SUPRIA w/guideShot Option?

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 SUPRIA w/guideShot Option?

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

Other records listing Hitachi Medical Systems America, 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.

K163528HITACHI Supria Whole-body X-ray CT System Phase 3K162079TRILLIUM Oval Head Coil 32K160152Trillium Oval V 5.1 MRI SystemK153547ECHELON Oval V 5.1 MRI System

Related Devices (Code: JAK)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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