Biolucent Applicator, Model Rta-Xx
FDA 510(k) K061241 · Biolucent, Inc.
510(k) numberK061241
Submission
- Device name
- Biolucent Applicator, Model Rta-Xx
- Applicant
- Biolucent, Inc.
Aliso Viejo, CA, US - Received
- May 3, 2006
- Decision date
- July 28, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
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| K251037 | Rectal ApplicatorJAQ · Traditional | Nucletron B.V. | 12/19/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems | 11/19/2025SE |
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| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional | Varian Medical Systems, Inc. | 03/03/2025SE |
| K241764 | Mould Probe MR SafeJAQ · Traditional | Varian Medical Systems, Inc. | 01/10/2025SE |
| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special | Braxx Biotech Co., Ltd. | 11/19/2024SE |
More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K070659 | Biolucent Applicator KitJAQ · Special | 04/04/2007SESU |
| K062830 | Biolucent Applicator KitJAQ · Special | 10/20/2006SE |
| K062141 | Mammopad Radiolucent CushionIYX · Traditional | 09/13/2006SE |
| K053595 | Curay Custom Seed ArrayKXK · Traditional | 02/28/2006SE |
| K003795 | Biolucent Mammography CushionIZH · Traditional | 02/14/2001SE |
Questions and answers
When was Biolucent Applicator, Model Rta-Xx cleared by the FDA?
Biolucent Applicator, Model Rta-Xx (K061241) received a 510(k) decision of Substantially Equivalent on July 28, 2006, 86 days after the submission was received.
What is the product code of K061241?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.