510(k) K131822
K131822 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "ULTRAEXTEND USWS-900A V2.1 AND V3.1". The FDA issued a decision of Substantially Equivalent on July 23, 2013. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2013
- Date Received
- June 20, 2013
- 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