510(k) K101228
K101228 is an FDA 510(k) premarket notification submitted by Mirada Medical, Ltd. for the device "MIRADA XD". The FDA issued a decision of Substantially Equivalent on Jun 23, 2010. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Mirada Medical, Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 2010
- Date Received
- May 3, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)