FDA 510(k)

SANGRAY

K-Number: K172087 · 2017-10-27

Decision Date2017-10-27

Product CodeMOT

DecisionSubstantially Equivalent

Device Summary

SANGRAY is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K172087. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANGRAY?

SANGRAY is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Hitachi , Ltd.. The 510(k) number is K172087.

When did SANGRAY receive FDA 510(k) clearance?

SANGRAY received FDA 510(k) clearance on 2017-10-27, under 510(k) number K172087.

Who is the listed applicant for SANGRAY?

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

What is the FDA product code for SANGRAY?

The FDA product code for SANGRAY is MOT.

Other records listing Hitachi , Ltd. 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.

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Related Devices (Code: MOT)

K201177RadGil2R3 X-Ray L.L.C K181737Raycell MK1Best Theratronics Limited K161324Raycell Mk2Best Theratronics Limited

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.