The following data is part of a premarket notification filed by Medical Imaging Electronics America, Inc. with the FDA for Scintron Iv.
| Device ID | K953193 |
| 510k Number | K953193 |
| Device Name: | SCINTRON IV |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MEDICAL IMAGING ELECTRONICS AMERICA, INC. 2340 BRICKVALE Elk Grove Village, IL 60007 |
| Contact | John H Loebel |
| Correspondent | John H Loebel MEDICAL IMAGING ELECTRONICS AMERICA, INC. 2340 BRICKVALE Elk Grove Village, IL 60007 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1995-10-24 |