The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Transact: Attenuation Correction System For The Apex Cardial Gamma Camera.
| Device ID | K952674 |
| 510k Number | K952674 |
| Device Name: | TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Kathleen Murray |
| Correspondent | Kathleen Murray ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1995-09-26 |