510(k) K012253
K012253 is an FDA 510(k) premarket notification submitted by Aloka Co., Ltd. for the device "SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on August 30, 2001. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Aloka Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2001
- Date Received
- July 18, 2001
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type