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FDA 510(k)

12MP Color Digital Mammography LCD Monitor CL-S1200

K-Number: K203733 · 2021-06-29

ApplicantJvckenwood Corporation
Decision Date2021-06-29
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

12MP Color Digital Mammography LCD Monitor CL-S1200 is a medical device manufactured by Jvckenwood Corporation. It received FDA 510(k) clearance on 2021-06-29 under approval number K203733. 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 12MP Color Digital Mammography LCD Monitor CL-S1200?

12MP Color Digital Mammography LCD Monitor CL-S1200 is a medical device that received FDA 510(k) clearance on 2021-06-29. It is manufactured by Jvckenwood Corporation. The 510(k) number is K203733.

When was 12MP Color Digital Mammography LCD Monitor CL-S1200 approved by the FDA?

12MP Color Digital Mammography LCD Monitor CL-S1200 received FDA 510(k) clearance on 2021-06-29, under approval number K203733.

What company makes 12MP Color Digital Mammography LCD Monitor CL-S1200?

12MP Color Digital Mammography LCD Monitor CL-S1200 is manufactured by Jvckenwood Corporation.

What is the FDA product code for 12MP Color Digital Mammography LCD Monitor CL-S1200?

The FDA product code for 12MP Color Digital Mammography LCD Monitor CL-S1200 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 K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300

View all 11 devices →

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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