The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Wba - I.r.i.s..
| Device ID | K842895 |
| 510k Number | K842895 |
| Device Name: | WBA - I.R.I.S. |
| Classification | Scanner, Whole Body, Nuclear |
| Applicant | SIEMENS GAMMASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAM |
| CFR Regulation Number | 892.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-08-27 |