FDA.reportPublic FDA data

Respiratory Gating for Scanners (RGSC)

Primary DI
00856100006196
Brand
Respiratory Gating for Scanners (RGSC)
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
2.0
Published
2022-04-21
Public version status
Update
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
K213927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213927000Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc.2022-01-14JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856100006196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856100006196008561000061968561000061960856100006196

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009120817
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesGM11013450GM110134502025-05-21
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRGM11012580GM110125802025-05-16
00816389029699Assembly module, CT/ MRGM11012910GM110129102025-05-16
00816389029743Retraction Nut CT/MRGM11012960GM110129602025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorGM11010740GM110107402024-11-19
00850800006074Vitesse5.0Vitesse 5.02024-11-01
00816389020245Crook Prostate Template for 2.0 mm needlesGM11012230GM110122302024-02-19
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointGM11009580GM110095802023-05-05
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointGM11009550GM110095502023-04-28
008105630220322.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
008105630220492.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
008105630220562.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20
008105630220632.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalPC-2.1SL2023-04-20
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmGM11013240GM110132402019-11-06
00816389021242Titanium-Fletcher-Suit-Delclos-style Applicator Set (Flexible Geometry)AL13030001AL130300012016-09-19
00816389021297X-ray marker wire, 160 cm x 0.6, channel 1AL13116000AL131160002016-09-19
00816389021310X-ray marker wire, 160 cm x 0.6, channel 3AL13118000AL131180002016-09-19
00816389021747Central clamping mechanismGM11000860GM110008602016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmGM11000890GM110008902016-09-23
00816389021792Colpostats for 20mm spread, pairGM11000910GM110009102016-09-19

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
00856100006493Respiratory Gating for ScannersVARIAN MEDICAL SYSTEMS, 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