FDA.reportPublic FDA data

Beacon Care Package - Soft Tissue (17G)

Primary DI
00850011006047
Brand
Beacon Care Package - Soft Tissue (17G)
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
ASM0607-001
Catalog number
ASM0607-001
Device description
The Beacon transponder is an implantable wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The Beacon Care package consists of three Beacon transponders, each with a dedicated introducer needle. The Beacon transponders are implanted in or near the treatment target. The resonance signal is used to measure the location of the transponder, by the Calypso System. The BCP-Soft Tissue many only be used with the Calypso System v3.0 or higher.
Published
2016-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

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
K152761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152761000Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)Varian Medical Systems, Inc.2015-11-25IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011006047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011006047008500110060478500110060470850011006047

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge17Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)827-4265xxx@xxx.xxx

Regulatory Flags#

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

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