The following data is part of a premarket notification filed by Spectrum Dynamics (israel) Ltd. with the FDA for Cardiac Scanner And Processing System.
| Device ID | K110507 |
| 510k Number | K110507 |
| Device Name: | CARDIAC SCANNER AND PROCESSING SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SPECTRUM DYNAMICS (ISRAEL) LTD. 1 HA'RAKEFET ST. Zichron Yaacov, IL 30900 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon SPECTRUM DYNAMICS (ISRAEL) LTD. 1 HA'RAKEFET ST. Zichron Yaacov, IL 30900 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-22 |
| Decision Date | 2011-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290108670059 | K110507 | 000 |
| 07290108670042 | K110507 | 000 |
| 07290108670035 | K110507 | 000 |
| 07290108670028 | K110507 | 000 |
| 07290108670011 | K110507 | 000 |
| 07290108670004 | K110507 | 000 |