FDA.reportPublic FDA data

Calypso Beacon Care Package-Lung

Primary DI
00850011006122
Brand
Calypso Beacon Care Package-Lung
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
2
Catalog number
ASM0341
Published
2019-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170570000Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.2018-04-06IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011006122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011006122008500110061228500110061220850011006122

GMDN Terms#

Term, Definition table
TermDefinition
Implanted-marker patient positioning systemAn assembly of devices used primarily in radiation therapy applications, for radiation treatment planning, and during therapy treatment to align and monitor a patient's position relative to the isocenter of a radiation therapy system (e.g., a linear accelerator). It detects electromagnetic signals provided by passive implanted markers (transponders) which have been surgically implanted in or near the target site prior to the treatment. This enables accurate positioning and tracking of all information throughout the treatment phase and helps to ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070809675
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856100006493Respiratory Gating for Scanners2.12026-06-05
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmGM11014100GM110141002026-06-02
00816389020191Applicator and Dilator for Proctoscope ø26 mmGM11014310GM110143102026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmGM11014410GM110144102026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014110GM110141102026-05-26
00816389028104Proctoscope ø 26 mmGM11014120GM110141202026-05-26
00816389028111Dilator for Proctoscope ø 26 mmGM11014130GM110141302026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmGM11014150GM110141502026-05-26
00816389028135Fixation ScrewGM11014160GM110141602026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmGM11014200GM110142002026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014210GM110142102026-05-26
00816389028166Proctoscope ø 30 mmGM11014220GM110142202026-05-26
00816389028173Dilator for Proctoscope ø 30 mmGM11014230GM110142302026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmGM11014250GM110142502026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014170GM110141702026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014270GM110142702026-05-26
00850800006074Vitesee5.0Vitesse 5.02024-11-01
00810563022032ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20

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00841439115305MultiFix 2QfixIYE2026-06-04
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00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
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08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
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08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
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