Standard Breast Boards; Deluxe Breast Board
FDA 510(k) K905007 · Bionix Development Corp.
510(k) numberK905007
Submission
- Device name
- Standard Breast Boards; Deluxe Breast Board
- Applicant
- Bionix Development Corp.
Toledo, OH, US - Received
- November 6, 1990
- Decision date
- February 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | Radformation, Inc. | 08/31/2026SE |
| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | Manteia Technologies Co., Ltd. | 08/26/2026SE |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 08/03/2026SE |
| K252937 | ThinkQA 3IYE · Traditional | Dosisoft SA | 06/12/2026SE |
| K253004 | Luna 3DIYE · Traditional | Lap GmbH Laser Applikationen | 06/04/2026SE |
| K260792 | AerFrame Patient Immobilization System (AFPIS)IYE · Traditional | Stabilix, LLC | 05/08/2026SE |
| K252258 | Veriqa RT Epid 3DIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten… | 04/15/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | Radformation, Inc. | 04/03/2026SE |
| K253012 | AlignRT Plus (8.0)IYE · Traditional | Vision Rt, Ltd. | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 01/21/2026SE |
More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K180605 | GastroFlushKNT · Traditional | 10/24/2018SE |
| K153270 | TruGuard Custom Tongue and Jaw PositionerIYE · Traditional | 03/08/2016SE |
| K123411 | Little Angels Swaddling BlanketPDH · Traditional | 03/07/2013SE |
| K120335 | Embrace ThermoplasticIYE · Traditional | 05/03/2012SE |
| K100691 | Omni V SBRT Positioning System, Model RT-4500IYE · Traditional | 05/11/2010SE |
| K100264 | T-Form Extremity Immobilizer, Model RT-6060IYE · Traditional | 04/09/2010SE |
| K050701 | Thigh and Foot Positioner, Suprone Plus, Model RT-6010IYE · Traditional | 04/01/2005SE |
| K040773 | Pelvis Bellyboard Plus Patient Positioning SystemIYE · Traditional | 04/09/2004SE |
| K030051 | Versaboard, Model 7040IYE · Traditional | 04/04/2003SE |
| K933614 | Pituitary BoardIYE · Traditional | 10/07/1993SE |
Questions and answers
When was Standard Breast Boards; Deluxe Breast Board cleared by the FDA?
Standard Breast Boards; Deluxe Breast Board (K905007) received a 510(k) decision of Substantially Equivalent on February 12, 1991, 98 days after the submission was received.
What is the product code of K905007?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.