The following data is part of a premarket notification filed by Beijing East Whale Imaging Technology Co., Ltd. with the FDA for Digiarc 100au+.
| Device ID | K141672 |
| 510k Number | K141672 |
| Device Name: | DIGIARC 100AU+ |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. B2-2 NEW CITY INDUSTRIAL PARK, NO. 9 KECHUANG 2ND ST., YIZHUANG Beijing, CN 100023 |
| Contact | June Li |
| Correspondent | June Li BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. B2-2 NEW CITY INDUSTRIAL PARK, NO. 9 KECHUANG 2ND ST., YIZHUANG Beijing, CN 100023 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2014-07-31 |
| Summary: | summary |