510(k) K141672
K141672 is an FDA 510(k) premarket notification submitted by Beijing East Whale Imaging Technology Co., Ltd. for the device "DIGIARC 100AU+". The FDA issued a decision of Substantially Equivalent on July 31, 2014. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Beijing East Whale Imaging Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2014
- Date Received
- June 23, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
Fluoroscopy of the human body.