The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Diagnostic Ultrasound System Fazone Cb.
| Device ID | K110202 |
| 510k Number | K110202 |
| Device Name: | FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 |
| Contact | Katherine Y Choi |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | 2011-01-24 |
| Decision Date | 2011-02-08 |
| Summary: | summary |