Jvckenwood Corporation is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.
Jvckenwood Corporation - FDA 510(k) Cleared Devices
Recent clearances: 3MP Color LCD Monitor (CL-S301), 8MP Color LCD Monitor CL-R813, 6MP Color LCD Monitor CL-S600
22
Total
22
Cleared
0
Denied
Jvckenwood Corporation, is a Japanese electronics manufacturer with a manufacturing facility in Nagano-Ken, Japan. The company specializes in medical display technology for diagnostic imaging applications.
Jvckenwood has received 22 FDA 510(k) clearances from 22 total submissions since 2013. The company focuses exclusively on Radiology devices, with no denied submissions on record. The latest clearance was in 2024, confirming active regulatory engagement.
The company's cleared portfolio consists primarily of color and monochrome LCD monitors for medical imaging. These include models ranging from 2MP to 12MP resolution, with specialized variants for digital mammography applications. Products serve diagnostic imaging workflows in clinical and hospital settings.
Explore the complete list of device names, product codes, and individual clearance dates in the database.
FDA 510(k) Regulatory Record - Jvckenwood Corporation
22 devices
Cleared
Aug 01, 2024
3MP Color LCD Monitor (CL-S301)
Radiology
101d
Cleared
Dec 21, 2022
8MP Color LCD Monitor CL-R813
Radiology
90d
Cleared
Dec 16, 2021
6MP Color LCD Monitor CL-S600
Radiology
90d
Cleared
Jun 29, 2021
12MP Color Digital Mammography LCD Monitor CL-S1200
Radiology
190d
Cleared
Apr 23, 2021
2MP Monochrome LCD Monitor MS-S200
Radiology
77d
Cleared
Feb 21, 2020
3MP Monochrome Digital Mammography LCD Monitor MS-S300
Radiology
30d
Cleared
Jul 02, 2019
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
Radiology
64d
Cleared
Oct 03, 2018
2MP Color LCD Monitor CL-R211
Radiology
19d
Cleared
Dec 14, 2017
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
Radiology
42d
Cleared
Sep 08, 2016
2MP Color LCD Monitor CCL214 (CL21214)
Radiology
59d
Cleared
Feb 23, 2016
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
Radiology
18d
Cleared
May 27, 2015
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
Radiology
28d
Cleared
May 08, 2015
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
Radiology
23d
Cleared
Nov 12, 2014
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
Radiology
16d
Cleared
Oct 03, 2014
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
Radiology
24d
Cleared
Oct 03, 2014
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
Radiology
24d
Cleared
Feb 19, 2014
30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)
Radiology
22d
Cleared
Jan 06, 2014
21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2...
Radiology
35d
Cleared
Dec 19, 2013
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
Radiology
35d
Cleared
Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)
Radiology
47d
Cleared
Dec 03, 2013
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
Radiology
47d
Cleared
Jul 18, 2013
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
Radiology
86d