FDA.reportPublic FDA data

Chronos Imaging LLC

Primary DI
10850012223136
Brand
Chronos Imaging LLC
Company
CHRONOS IMAGING LLC
Model
CL200 0407
Catalog number
4535-775-21472
Device description
X-Ray Tube Housing Assembly
Published
2025-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITYAssembly, Tube Housing, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITYAssembly, Tube Housing, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850012223136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085001222313610850012223136

GMDN Terms#

Term, Definition table
TermDefinition
X-ray tube housing assembly, diagnosticA metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system.

Regulatory Flags#

DUNS number
115271849
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850012223167Chronos Imaging LLCAU200-C40+LMB4535-775-217472025-12-29
10850012223129Chronos Imaging LLCS532Q4535-775-206172021-04-26
10850012223082Chronos Imaging LLCAU2004535-775-100482020-06-22
10850012223099Chronos Imaging LLCAU200-C404535-775-100492020-06-22
10850012223105Chronos Imaging LLCAU2404535-775-100502020-06-22
10850012223006Chronos Imaging LLCDA135CTE9896-055-808002020-03-23
10850012223013Chronos Imaging LLCDA165NP9896-055-839012020-03-23
10850012223020Chronos Imaging LLCS532B9896-055-957022020-03-23
10850012223037Chronos Imaging LLCS532Q9896-055-959022020-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973915530430MingweiMingWei Medical Technology(Suzhou)Co.,LTDITY2026-01-16
10850012223167Chronos Imaging LLCCHRONOS IMAGING LLCITY2025-12-29
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCITY2025-12-05
08059307491563RTM 77 HSI.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPAITY2025-11-14
08059307491594RTM 780 HSI.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPAITY2025-11-14
00195278723963NAGE Healthcare Japan CorporationITY2025-10-15
06971564631563RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-30
06971564630153RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
06971564630160RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
06971564630214RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-08-11
00884838127517CT XS Tube CPOPhilips Medical Systems DMC GmbHITY2025-07-31
04580274412397Rotating Anode X-ray Tube AssemblyCANON ELECTRON TUBES & DEVICES CO. LTD.ITY2025-06-16
06971564631396RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-04-24
04580274412366Rotating Anode X-ray Tube AssemblyCANON ELECTRON TUBES & DEVICES CO. LTD.ITY2025-03-14
04580274412373Rotating Anode X-ray Tube AssemblyCANON ELECTRON TUBES & DEVICES CO. LTD.ITY2025-03-14
06971564631198RADIIHangzhou Kailong Medical Instruments Co.,Ltd.ITY2025-01-22
00195278770271VolusonGE Healthcare Austria GmbH & Co OGITY2025-01-07
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