510(k) K090649
K090649 is an FDA 510(k) premarket notification submitted by Virtual Radiologic Corporation for the device "VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE". The FDA issued a decision of Substantially Equivalent on March 27, 2009. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Virtual Radiologic Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2009
- Date Received
- March 11, 2009
- 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