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FDA 510(k)

3MP Monochrome Digital Mammography LCD Monitor MS-S300

K-Number: K200161 · 2020-02-21

ApplicantJvckenwood Corporation
Decision Date2020-02-21
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3MP Monochrome Digital Mammography LCD Monitor MS-S300 is a medical device manufactured by Jvckenwood Corporation. It received FDA 510(k) clearance on 2020-02-21 under approval number K200161. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3MP Monochrome Digital Mammography LCD Monitor MS-S300?

3MP Monochrome Digital Mammography LCD Monitor MS-S300 is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Jvckenwood Corporation. The 510(k) number is K200161.

When was 3MP Monochrome Digital Mammography LCD Monitor MS-S300 approved by the FDA?

3MP Monochrome Digital Mammography LCD Monitor MS-S300 received FDA 510(k) clearance on 2020-02-21, under approval number K200161.

What company makes 3MP Monochrome Digital Mammography LCD Monitor MS-S300?

3MP Monochrome Digital Mammography LCD Monitor MS-S300 is manufactured by Jvckenwood Corporation.

What is the FDA product code for 3MP Monochrome Digital Mammography LCD Monitor MS-S300?

The FDA product code for 3MP Monochrome Digital Mammography LCD Monitor MS-S300 is PGY.

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Other Devices by Jvckenwood Corporation

K1618952MP Color LCD Monitor CCL214 (CL21214) K1603265MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) K1734342MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 K1825392MP Color LCD Monitor CL-R211 K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 K2129856MP Color LCD Monitor CL-S600

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Related Devices (Code: PGY)

K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation K1625278MP Color LCD Monitor (C81W+)Shenzhen Beacon Display Technology Co., Ltd. K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. K161229Mammo Tomosynthesis (MDMG-5221)Barco N.V.

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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