Aos Interstitial Templates, Needles & Accessories
FDA 510(k) K062823 · Alpha-Omega Services, Inc.
510(k) numberK062823
Submission
- Device name
- Aos Interstitial Templates, Needles & Accessories
- Applicant
- Alpha-Omega Services, Inc.
Bellflower, CA, US - Received
- September 20, 2006
- Decision date
- May 29, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | Varian Medical Systems | 05/20/2026SE |
| K251037 | Rectal ApplicatorJAQ · Traditional | Nucletron B.V. | 12/19/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems | 11/19/2025SE |
| K250299 | CT/ MR Tandem and Ovoid SetJAQ · Traditional | Varian Medical Systems, Inc. | 05/09/2025SE |
| K250289 | Intracavitary/Interstitial SystemJAQ · Traditional | Varian Medical Systems | 04/25/2025SE |
| 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 |
|---|---|---|
| K233628 | AOS Interstitial Templates, Needles, and AccessoriesJAQ · Traditional | 07/10/2024SE |
| K233626 | AOS Marker Seeds (SMG0242-025)JAQ · Traditional | 07/02/2024SE |
| K102811 | Aos Orion IR-192 Source CableKXK · Traditional | 06/02/2011SE |
| K062824 | Aos Universal Conecting Guide TubeJAQ · Traditional | 07/03/2007SE |
| K062826 | Aos Implant Tubes, Implant Needles & Retaining BottonsJAQ · Traditional | 05/22/2007SE |
| K062825 | Aos Marker SeedsKXK · Traditional | 05/22/2007SE |
| K991571 | 10 Curie Irdium 192, CSN00100-192KXK · Traditional | 02/22/2000SE |
| K964910 | Aos Universal Connecting Guide Tube for High Dose Rate AfterloadersJAQ · Traditional | 03/10/1997SE |
Questions and answers
When was Aos Interstitial Templates, Needles & Accessories cleared by the FDA?
Aos Interstitial Templates, Needles & Accessories (K062823) received a 510(k) decision of Substantially Equivalent on May 29, 2007, 251 days after the submission was received.
What is the product code of K062823?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.