The following data is part of a premarket notification filed by Medical Imaging Technology Assoc., Inc. with the FDA for Gammacon Image Translation System.
| Device ID | K962955 |
| 510k Number | K962955 |
| Device Name: | GAMMACON IMAGE TRANSLATION SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MEDICAL IMAGING TECHNOLOGY ASSOC., INC. 29 MAIN ST. P.O. BOX 197 Mainland, PA 19451 |
| Contact | Peter F Heckman |
| Correspondent | Peter F Heckman MEDICAL IMAGING TECHNOLOGY ASSOC., INC. 29 MAIN ST. P.O. BOX 197 Mainland, PA 19451 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-30 |
| Decision Date | 1996-10-28 |