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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 the device name listed in this FDA 510(k) record. The listed applicant is Jvckenwood Corporation. It received FDA 510(k) clearance on 2021-06-29 under 510(k) 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. The listed applicant is Jvckenwood Corporation. The 510(k) number is K203733.

When did 12MP Color Digital Mammography LCD Monitor CL-S1200 receive FDA 510(k) clearance?

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

Who is the listed applicant for 12MP Color Digital Mammography LCD Monitor CL-S1200?

The FDA 510(k) record lists Jvckenwood Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Jvckenwood Corporation 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.

K2411053MP Color LCD Monitor (CL-S301)K2228648MP Color LCD Monitor CL-R813K2129856MP Color LCD Monitor CL-S600K2103452MP Monochrome LCD Monitor MS-S200K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500

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Related Devices (Code: PGY)

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.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.

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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