The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Neucoloncare.
| Device ID | K110077 |
| 510k Number | K110077 |
| Device Name: | NEUCOLONCARE |
| Classification | System, Image Processing, Radiological |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSRTIAL AREA Shenyang, Liaoning, CN 110179 |
| Contact | Tian Yeuhui |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-01-11 |
| Decision Date | 2011-01-28 |
| Summary: | summary |