The following data is part of a premarket notification filed by Neusoft Digital Medical Systems Co., Ltd. with the FDA for Ct-c3000 Spiral Ct Scanner System.
| Device ID | K020913 |
| 510k Number | K020913 |
| Device Name: | CT-C3000 SPIRAL CT SCANNER SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning, CN 110004 |
| Contact | Wang Zhiqiang |
| Correspondent | Wolfram Gmelin TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-03-21 |
| Decision Date | 2002-04-03 |
| Summary: | summary |