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FDA 510(k)

PROVU (TM) DENTAL X-RAY SYSTEM

K-Number: K102573 · 2011-06-30

ApplicantAdvanced Image Science, Inc.
Decision Date2011-06-30
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROVU (TM) DENTAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Image Science, Inc.. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K102573. 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 PROVU (TM) DENTAL X-RAY SYSTEM?

PROVU (TM) DENTAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Advanced Image Science, Inc.. The 510(k) number is K102573.

When did PROVU (TM) DENTAL X-RAY SYSTEM receive FDA 510(k) clearance?

PROVU (TM) DENTAL X-RAY SYSTEM received FDA 510(k) clearance on 2011-06-30, under 510(k) number K102573.

Who is the listed applicant for PROVU (TM) DENTAL X-RAY SYSTEM?

The FDA 510(k) record lists Advanced Image Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROVU (TM) DENTAL X-RAY SYSTEM?

The FDA product code for PROVU (TM) DENTAL X-RAY SYSTEM is EAP.

Related Clinical Trials

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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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK093453MODIFICATION 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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