The following data is part of a premarket notification filed by Orbital Therapy, Llc with the FDA for Clearvue Prone Breast Treatment Table.
| Device ID | K090349 |
| 510k Number | K090349 |
| Device Name: | CLEARVUE PRONE BREAST TREATMENT TABLE |
| Classification | Accelerator, Linear, Medical |
| Applicant | ORBITAL THERAPY, LLC 11 MYSTIC AVENUE Winchester, MA 01890 |
| Contact | Chas Burr |
| Correspondent | Chas Burr ORBITAL THERAPY, LLC 11 MYSTIC AVENUE Winchester, MA 01890 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-11 |
| Decision Date | 2009-03-09 |
| Summary: | summary |