FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
K Number: K151134
·
Decision May 27, 2015
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
130
Applicant Total
11
Review Days
28
Basic Information
- Device Name
- 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
- K Number
- K151134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JVC KENWOOD CORPORATION
- Date Received
- April 29, 2015
- Decision Date
- May 27, 2015
- Product Code
- PGY
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PGY), ordered by most recent decision date.
RadiForce RX570; RadiForce RX570-AR
FDA 510(k)
FDA Class 2
·Radiology
LCD Monitors C310S, G310S, C316S, G316S, C616W
FDA 510(k)
FDA Class 2
·Radiology
Coronis OneLook
FDA 510(k)
FDA Class 2
·Radiology
3MP Color LCD Monitor (CL-S301)
FDA 510(k)
FDA Class 2
·Radiology
RadiForce RX670; RadiForce RX670-AR
FDA 510(k)
FDA Class 2
·Radiology
21.3 5MP Color LCD Display UMD5-21B01
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by JVC KENWOOD CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K151007 | 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) | May 8, 2015 | Substantially Equivalent |
| K143076 | 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) | Nov 12, 2014 | Substantially Equivalent |
| K142536 | 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) | Oct 3, 2014 | Substantially Equivalent |
| K142540 | 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) | Oct 3, 2014 | Substantially Equivalent |
| K140214 | 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) | Feb 19, 2014 | Substantially Equivalent |
| K133686 | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) | Jan 6, 2014 | Substantially Equivalent |
| K133511 | 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) | Dec 19, 2013 | Substantially Equivalent |
| K133185 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) | Dec 3, 2013 | Substantially Equivalent |
| K133181 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) | Dec 3, 2013 | Substantially Equivalent |
| K131137 | 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) | Jul 18, 2013 | Substantially Equivalent |