510(k) K133966
K133966 is an FDA 510(k) premarket notification submitted by Halifax Biomedical, Inc. for the device "MODEL-BASED RSA SOFTWARE". The FDA issued a decision of Substantially Equivalent on Mar 6, 2014. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Halifax Biomedical, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 2014
- Date Received
- Dec 24, 2013
- 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
- 510(k)