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FDA 510(k)

21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR

K-Number: K111496 · 2011-09-26

ApplicantTotoku Electric Co., Ltd.
Decision Date2011-09-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR 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 2011-09-26 under 510(k) number K111496. 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 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR?

21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Totoku Electric Co., Ltd.. The 510(k) number is K111496.

When did 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR receive FDA 510(k) clearance?

21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR received FDA 510(k) clearance on 2011-09-26, under 510(k) number K111496.

Who is the listed applicant for 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR?

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 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR?

The FDA product code for 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR is LLZ.

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Other records listing Totoku Electric 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.

K11344321.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)K11313621.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)K112145MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2K11260421.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)K09272820.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)K09094721.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)

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Related Devices (Code: LLZ)

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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