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FDA 510(k)

INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY

K-Number: K021718 · 2002-08-15

ApplicantSuni Imaging Microsystems, Inc.
Decision Date2002-08-15
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Suni Imaging Microsystems, Inc.. It received FDA 510(k) clearance on 2002-08-15 under 510(k) number K021718. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY?

INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY is a medical device that received FDA 510(k) clearance on 2002-08-15. The listed applicant is Suni Imaging Microsystems, Inc.. The 510(k) number is K021718.

When did INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY receive FDA 510(k) clearance?

INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY received FDA 510(k) clearance on 2002-08-15, under 510(k) number K021718.

Who is the listed applicant for INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY?

The FDA 510(k) record lists Suni Imaging Microsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY?

The FDA product code for INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY is MUH.

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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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