FDA.reportPublic FDA data

Respiratory Gating for Scanners

Primary DI
00856100006493
Brand
Respiratory Gating for Scanners
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
2.1
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K253026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253026000Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.2026-06-04JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856100006493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856100006493008561000064938561000064930856100006493

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854393006084Velocity4.3Velocity 4.32026-07-16
10816389027234Cleaning Cap, dark blue (pack of 25)GM11010770GM110107702016-09-22
00810563021035SynchroWave ST Antenna22-17025-315SWST-14152022-02-18
00810563021042SynchroWave ST Antenna22-17025-320SWST-14202022-02-18
008105630206872.4mm V-Probe™ Cryoprobe Right AngleDP35-0902-109CVA2400RA2022-02-18
008105630207861.7 mm RenalCryo™ CryoprobeDP35-0942-203RS-172022-02-18
008105630207931.7 mm RenalCryo™ CryoprobeDP35-0942-208RS-172022-02-18
008105630208091.7 mm Long Shaft RenalCryo™ CryoprobeDP35-0942-204RS-17L2022-02-18
008105630208161.7 mm Long Shaft RenalCryo™ CryoprobeDP35-0942-209RS-17L2022-02-18
008105630208232.4mm RenalCryo™ CryoprobeDP35-0943-203RS-242022-02-18
008105630208472.4mm Long Shaft RenalCryo™ CryoprobeDP35-0943-204RS-24L2022-02-18
008105630208613.8 mm RenalCryo™ CryoprobeDP35-0793-201R3.82022-02-18
008105630208783.8 mm RenalCryo™ CryoprobeDP35-0793-203R3.82022-02-18
008105630208853.8 mm Long Shaft RenalCryo™ CryoprobeDP35-0793-202R3.8L2022-02-18
008105630208923.8 mm Long Shaft RenalCryo™ CryoprobeDP35-0793-204R3.8L2022-02-18
00810563020908TempProbe™ DeviceDP40-0015-213CRYO-55-F2022-02-18
00810563020915Prostate Procedure Probe PackDP35-0965-101CRYO-204-V2022-02-18
00810563020939Prostate Procedure Probe PackDP35-0595-108CRYO-207-V2022-02-18
008105630209608mm CryoprobeDP35-0215-102CRYO-48-F2022-02-18
008163890289062.4mm V-Probe™ CryoprobeDP35-0902-101CVA24002022-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAK2026-07-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12