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FDA 510(k)

21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)

K-Number: K090947 · 2010-08-16

ApplicantTotoku Electric Co., Ltd.
Decision Date2010-08-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) is the device name listed in this FDA 510(k) record. The listed applicant is Totoku Electric Co., Ltd.. It received FDA 510(k) clearance on 2010-08-16 under 510(k) number K090947. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)?

21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) is a medical device that received FDA 510(k) clearance on 2010-08-16. The listed applicant is Totoku Electric Co., Ltd.. The 510(k) number is K090947.

When did 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) receive FDA 510(k) clearance?

21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) received FDA 510(k) clearance on 2010-08-16, under 510(k) number K090947.

Who is the listed applicant for 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)?

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

What is the FDA product code for 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)?

The FDA product code for 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) is LLZ.

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Other records listing Totoku Electric Co., Ltd. as applicant

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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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