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FDA 510(k)

MEDICAL IMAGE PROCESSING UNIT

K-Number: K113360 · 2012-02-07

ApplicantHumanray Co,Ltd
Decision Date2012-02-07
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEDICAL IMAGE PROCESSING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Humanray Co,Ltd. It received FDA 510(k) clearance on 2012-02-07 under 510(k) number K113360. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAL IMAGE PROCESSING UNIT?

MEDICAL IMAGE PROCESSING UNIT is a medical device that received FDA 510(k) clearance on 2012-02-07. The listed applicant is Humanray Co,Ltd. The 510(k) number is K113360.

When did MEDICAL IMAGE PROCESSING UNIT receive FDA 510(k) clearance?

MEDICAL IMAGE PROCESSING UNIT received FDA 510(k) clearance on 2012-02-07, under 510(k) number K113360.

Who is the listed applicant for MEDICAL IMAGE PROCESSING UNIT?

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

What is the FDA product code for MEDICAL IMAGE PROCESSING UNIT?

The FDA product code for MEDICAL IMAGE PROCESSING UNIT is EAP.

Related Clinical Trials

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Other records listing Humanray Co,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.

K121132EZSENSOR P DIGITAL INTRAORAL SENSOR

Related Devices (Code: EAP)

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.

K102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K960819HELIODENT DSPelton & Crane Co.

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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