510(k) K111613
K111613 is an FDA 510(k) premarket notification submitted by Infinitt Co., Ltd. for the device "XELIS FUSION". The FDA issued a decision of Substantially Equivalent on Sep 8, 2011. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Infinitt Co., Ltd. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 8, 2011
- Date Received
- Jun 9, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)