Identity
- Trade Name
- AccuBoost® FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- Shielded Breast Applicator - Natural D 53mm FDA UDI
- Model / Reference
- 450106-02 FDA UDI
- Description
- Shielded Breast Applicator - Natural D 53mm FDA UDI
Identifiers
- Catalog Number
- ART-NATD-53 FDA UDI
- Primary DI / UDI-DI
- 00850306007063 FDA UDI
- 510(k) Number
- K062135 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 53 Millimeter FDA UDI
Category: General-purpose brachytherapy system applicator, manual
AccuBoost® by Advanced Radiation Therapy, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose brachytherapy system applicator, manual.
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- H.A.M. Tungsten Shield for 06-Channel Appl — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- H.A.M., 08-Chan, 130cm cath, Slot, Varian-Gammamed — MICK RADIO NUCLEAR INSTRUMENT, INC · Class II
- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
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Cleared under the same submission
K062135 also covers:
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Radiation Therapy, Llc
Sources (1)
- FDA UDI 5b5f0a81-27c5-4ecc-b315-9f3652acdfee 37 fields · synced May 30, 2026