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FDA 510(k)

DIGITAL X-RAY IMAGING SYSTEM

K-Number: K111103 · 2012-01-05

ApplicantRf Co., Ltd.
Decision Date2012-01-05
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGITAL X-RAY IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rf Co., Ltd.. It received FDA 510(k) clearance on 2012-01-05 under 510(k) number K111103. 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 DIGITAL X-RAY IMAGING SYSTEM?

DIGITAL X-RAY IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-05. The listed applicant is Rf Co., Ltd.. The 510(k) number is K111103.

When did DIGITAL X-RAY IMAGING SYSTEM receive FDA 510(k) clearance?

DIGITAL X-RAY IMAGING SYSTEM received FDA 510(k) clearance on 2012-01-05, under 510(k) number K111103.

Who is the listed applicant for DIGITAL X-RAY IMAGING SYSTEM?

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

What is the FDA product code for DIGITAL X-RAY IMAGING SYSTEM?

The FDA product code for DIGITAL X-RAY IMAGING SYSTEM is MUH.

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Related Devices (Code: MUH)

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

View on FDA Database →

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

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