UROCARE
System, Image Processing, Radiological
NEUSOFT MEDICAL SYSTEMS CO., LTD.
The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Urocare.
Pre-market Notification Details
| Device ID | K090552 |
| 510k Number | K090552 |
| Device Name: | UROCARE |
| Classification | System, Image Processing, Radiological |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSTRIAL AREA Shenyang, Liaoning, CN 110179 |
| Contact | Tian Yanfang |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-03-16 |
| Summary: | summary |
Trademark Results [UROCARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UROCARE 73512861 1392075 Live/Registered |
UROCARE PRODUCTS, INC. 1984-12-10 |
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