510(k) K101279
K101279 is an FDA 510(k) premarket notification submitted by Invia for the device "CORRIDOR4DM V2010 MODEL: V2010". The FDA issued a decision of Substantially Equivalent on August 4, 2010. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Invia has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2010
- Date Received
- May 6, 2010
- 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