The following data is part of a premarket notification filed by General Electric Medical Systems with the FDA for Cardiq Analysis Iii.
| Device ID | K041267 |
| 510k Number | K041267 |
| Device Name: | CARDIQ ANALYSIS III |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. W-400 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-12 |
| Decision Date | 2004-05-27 |
| Summary: | summary |