The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Microdelta, Tc-99m-mag3 Renal Processing Program.
| Device ID | K905074 |
| 510k Number | K905074 |
| Device Name: | MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Contact | Dennis W Henkelman |
| Correspondent | Dennis W Henkelman SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-09 |
| Decision Date | 1991-06-21 |