The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Omni V Sbrt Positioning System, Model Rt-4500.
| Device ID | K100691 |
| 510k Number | K100691 |
| Device Name: | OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | James Huttner |
| Correspondent | James Huttner BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-10 |
| Decision Date | 2010-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817740020577 | K100691 | 000 |
| 00817740021284 | K100691 | 000 |
| 00817740021291 | K100691 | 000 |
| 00817740021307 | K100691 | 000 |
| 00817740021314 | K100691 | 000 |
| 00817740021321 | K100691 | 000 |
| 00817740021338 | K100691 | 000 |
| 00817740021345 | K100691 | 000 |
| 00817740021352 | K100691 | 000 |
| 08177400245002 | K100691 | 000 |