The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Flying Diagnostic Ultrasound System.
| Device ID | K083877 |
| 510k Number | K083877 |
| Device Name: | FLYING DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning, CN 110004 |
| Contact | Tian Yanfang |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-01-13 |
| Summary: | summary |