FDA.reportPublic FDA data

AccuBoost®

Primary DI
00850306007445
Brand
AccuBoost®
Company
ADVANCED RADIATION THERAPY, LLC
Model
450200-B4
Catalog number
ART-SDO-8-B
Device description
Shielded Breast Applicator - 8cm Round SDO Bottom
Published
2018-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAQSystem, Applicator, Radionuclide, Remote-Controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062135000ART SHIELDED BREAST APPLICATORAdvanced Radiation Therapy, LLC2006-11-07JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850306007445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850306007445008503060074458503060074450850306007445

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, manualA general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter8Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(978)649-0007info@accuboost.com

Regulatory Flags#

DUNS number
193415051
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850306007605PreciseRT450729ART-PA-MSPRT2021-09-27
00850306007513AccuBoost450102-01ART-PA-32019-12-03
00850306007520AccuBoost450126ART-PT2019-12-03
00850306007537AccuBoost450123-01ART-PA-PA2019-12-03
00850306007544AccuBoost450123-02PM-PA-PA2019-12-03
00850306007551AccuBoost450123-03DM-PA-PA2019-12-03
00850306007568AccuBoost450128ART-PT-DM2019-12-03
00850306007575AccuBoost450129ART-PA-MSDM2019-12-03
00850306007582AccuBoost450125-01ART-PA-MSLP2019-12-03
00850306007599AccuBoost450125-02PM-PA-MSLP2019-12-03
00850306007407AccuBoost®450200-B0ART-SDO-4-B2018-09-05
00850306007414AccuBoost®450200-B1ART-SDO-5-B2018-09-05
00850306007421AccuBoost®450200-B2ART-SDO-6-B2018-09-05
00850306007438AccuBoost®450200-B3ART-SDO-7-B2018-09-05
00850306007452AccuBoost®450201-B1ART-DRO-5-B2018-09-05
00850306007469AccuBoost®450201-B2ART-DRO-6-B2018-09-05
00850306007476AccuBoost®450201-B3ART-DRO-7-B2018-09-05
00850306007483AccuBoost®450201-B4ART-DRO-8-B2018-09-05
00850306007490AccuBoost®450202-B1ART-NATD-SDO-45-B2018-09-05
00850306007506AccuBoost®450202-B2ART-NATD-SDO-53-B2018-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-21
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029699Assembly module, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029712Retractor, 30 mm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029743Retraction Nut CT/MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorVARIAN MEDICAL SYSTEMS, INC.JAQ2024-11-19
00816389020245Crook Prostate Template for 2.0 mm needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-05-05
00816389029217Stainless steel needle 113mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029224Stainless steel needle 200mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceVARIAN MEDICAL SYSTEMS, INC.JAQ2022-01-09
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmVARIAN MEDICAL SYSTEMS, INC.JAQ2019-11-06
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009585Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009646Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20