The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Ivr Master.
| Device ID | K945389 |
| 510k Number | K945389 |
| Device Name: | IVR MASTER |
| Classification | System, Image Processing, Radiological |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Michael Fishback |
| Correspondent | Michael Fishback SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-03 |
| Decision Date | 1995-02-07 |