510(k) K140445
K140445 is an FDA 510(k) premarket notification submitted by Imaging Sciences International, LLC for the device "DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC". The FDA issued a decision of Substantially Equivalent on April 23, 2014. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Imaging Sciences International, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2014
- Date Received
- February 21, 2014
- Clearance Type
- Special
- 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