The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Cardioarc Series: Positioner C-arm Models No. 6896.001 And 6896.105.
| Device ID | K961690 |
| 510k Number | K961690 |
| Device Name: | CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | Oscar Khutoryansky |
| Correspondent | Oscar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-01 |
| Decision Date | 1996-06-27 |