510(k) K100691
K100691 is an FDA 510(k) premarket notification submitted by Bionix Development Corp. for the device "OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500". The FDA issued a decision of Substantially Equivalent on May 11, 2010. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Bionix Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2010
- Date Received
- March 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type