510(k) K121466
K121466 is an FDA 510(k) premarket notification submitted by Guidemia Technologies, LLC for the device "GUIDEMIA". The FDA issued a decision of Substantially Equivalent on May 31, 2012. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Guidemia Technologies, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2012
- Date Received
- May 17, 2012
- 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)