FDA.reportPublic FDA data

TOTOKU

Primary DI
04996005102909
Brand
TOTOKU
Company
JVC KENWOOD CORPORATION
Model
MS55i2/F
Device description
5MP Monochrome LCD Monitor ML21055-B2F0U
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PGYDisplay, Diagnostic Radiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGYDisplay, Diagnostic RadiologyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1603260005MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)Jvckenwood Corporation2016-02-23PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04996005102909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04996005102909049960051029094996005102909

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, monochromeA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in only one text/image colour, e.g., measured values or images from other devices. The information displayed will be limited (the view will become confusing to the user when too much information is shown). A keyboard may be connected for interactive manipulation of the data by the user. This GMDN code is the product identifier for the monitor only and does not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
713321040
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00046838501111JVCCL-S3012024-08-19
00046838002687JVCCL-R8132023-01-05
00046838076350JVCCCL358i2/N2017-04-01
00046838076367JVCCCL358i2/F2017-04-01
00046838076374JVCCCL550i2/N2017-04-01
00046838076381JVCCCL550i2/F2017-04-01
00046838076411JVCMS55i2 plus2017-09-01
00046838076435JVCMS55i2 plus2017-09-01
00046838076510JVCMS35i2/F2017-05-01
00046838076527JVCMS35i2/N2017-05-01
00046838076534JVCMS35i2/AR2017-05-01
00046838076541JVCMS25i2/F2017-05-01
00046838076558JVCMS25i2/N2017-05-01
00046838076565JVCMS25i2/AR2017-05-01
00046838076572JVCCCL258i2/N2017-05-01
00046838076589JVCCCL258i2/AR2017-05-01
00046838076596JVCCCL258i2/F2017-05-01
00046838076602JVCCCL650i2/N2017-05-01
00046838076619JVCCCL650i2/AR2017-05-01
00046838076626JVCCCL2142017-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069300RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047069362RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072676RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072683RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072843RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072904RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072935RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072973RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073055RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073185RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073208RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073277RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073338RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073376RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073444RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073468RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073475RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073611RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073673RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073703RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073819RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073871RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073895RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074311RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074373RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074441RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074588RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074601RadiForce®EIZO CORPORATIONPGY2026-07-22
08809241513148CW60NWIDE corporationPGY2026-07-16
08809241513155CL24NWIDE corporationPGY2026-07-16