The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Ultrasonic Processors Su-1 Platinum And Su-1.
| Device ID | K153206 |
| 510k Number | K153206 |
| Device Name: | Fujifilm Ultrasonic Processors SU-1 PLATINUM And SU-1 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Shraddha More |
| Correspondent | Shraddha More FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410332377 | K153206 | 000 |
| 04547410332360 | K153206 | 000 |
| 04547410332353 | K153206 | 000 |
| 04547410332346 | K153206 | 000 |