The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Model Ff Sonic Us-750 Xt Diagnostic Ultrasound System 3d Imaging Unit.
| Device ID | K082656 |
| 510k Number | K082656 |
| Device Name: | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | Loran Van Noy |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2008-09-30 |
| Summary: | summary |