FDA.reportPublic FDA data

IA-16LD/HS12

Primary DI
04540217026128
Brand
IA-16LD/HS12
Company
SHIMADZU CORPORATION
Model
532-16728-62
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012424000SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LMShimadzu Corp.2001-10-18JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04540217026128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04540217026128045402170261284540217026128

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image intensifierA device that converts an x-ray image into a light image, then to an electronic image and finally back to a light-based image of diminished size and increased brightness. It consists of a large evacuated glass envelope with four basic parts: 1) an input phosphor/fluorescent screen; 2) a photocathode; 3) an electrostatic focusing lens; and 4) an accelerating anode and output phosphor/fluorescent screen. This GMDN code includes single, dual and triple field intensifier designs. It is primarily used in fluoroscopic, angiographic, cine-fluorographic x-ray, and digital x-ray applications as it outputs an image small enough to be coupled to cine, television or spot-film cameras.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690558747
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04540217040872SONIALVISION G4503-78000-512019-08-14
04540217040889SONIALVISION G4503-78000-522019-08-14
04540217040896SONIALVISION G4503-78000-532019-08-14
04540217041022SONIALVISION G4566-10000-412019-08-14
04540217041039SONIALVISION G4566-10000-422019-08-14
04540217041046SONIALVISION G4566-10000-432019-08-14
04540217041053SONIALVISION G4566-10000-462019-08-14
04540217041060SONIALVISION G4566-10000-472019-08-14
04540217059539R-20J563-55050-312020-02-21
04540217059553Trinias503-79831-432019-05-31
04540217059607Trinias503-79823-432019-05-31
045402170607880.7/1.2JG326 D-265582-24825-422019-07-23
045402170608250.4/0.7JG326 D-265582-24838-112019-07-23
04540217061006Trinias503-79830-432019-05-31
04540217061099Trinias503-79832-432019-05-31
04540217061136Trinias503-79840-432019-05-31
045402170614260.7/1.2JG326 D-265582-24825-042019-07-23
045402170618840.6/1.2P324DK-85582-24486-502020-02-21
045402170618910.6/1.2P324DK-85582-24486-572020-02-21
045402170620340.6/1.2P13DK-85582-24476-502020-02-21

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