FDA.reportPublic FDA data

Gating Reflector Block

Primary DI
00856100006226
Brand
Gating Reflector Block
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
1.0
Published
2024-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAKSystem, x-ray, tomography, computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242874000Gating Reflector BlockVarian Medical Systems, Inc.2024-11-21JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856100006223PackageGS15In Commercial Distribution
00856100006226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085610000622310856100006223
00856100006226008561000062268561000062260856100006226

GMDN Terms#

Term, Definition table
TermDefinition
Real-time position management respiratory gating system, opticalAn assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It provides real-time position management (RPM) and involves optical-based tracking (e.g., video, infrared, laser) of the respiratory cycle to enable irradiation control during the procedure. It may include a tracking camera connected to a dedicated personal computer workstation and a reflective chest wall/abdominal marker.

Regulatory Flags#

DUNS number
009120817
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563022001Mandrin for 200 mm lengthGM11010450GM110104502024-02-16
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileGM11003800GM110038002016-09-23
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinGM11014710GM110147102024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinGM11014720GM110147202024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinGM11014730GM110147302024-02-16
00810563022018Mandrin for 320 mm lengthGM11010470GM110104702024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563021998Mandrin for 113 mm lengthGM11010390GM110103902024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleGM11003270GM110032702021-02-02
00816389022188Flexible probe, 2.8 mm diameter x 320 mmGM11002280GM110022802016-09-22
00816389022195Mould probe, ø 1.8 diameter x 320 mm, with mandrinGM11002290GM110022902016-09-19
00816389022478Mandrin for 320mm lengthGM11003100GM110031002016-09-23
00816389022553Mandrin for 113mm length NeedleGM11003340GM110033402016-09-22
00816389022935Catheter flap 200 mm x 290 mm x 10 mm, 40 channelsGM11003910GM110039102016-09-23
00816389024243Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needlesGM11007560GM110075602016-09-22
00816389024250Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needlesGM11007570GM110075702016-09-18
00816389024267Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needlesGM11007580GM110075802016-09-19
00816389025615Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrinGM11010750GM110107502016-09-22
00854393006084Velocity4.3Velocity 4.32026-07-16
10816389027234Cleaning Cap, dark blue (pack of 25)GM11010770GM110107702016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29