Quantix Cardiac Angiographic System
FDA 510(k) K850455 · Xre Corp.
510(k) numberK850455
Submission
- Device name
- Quantix Cardiac Angiographic System
- Applicant
- Xre Corp.
Littleton, MA, US - Received
- February 6, 1985
- Decision date
- May 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K923654 | Poly Diagnost CDXIZI · Traditional | 11/20/1992SE |
| K913685 | Unicath Ep.IZI · Traditional | 11/07/1991SE |
| K912416 | Angiographic or Fluoroscopic X-Ray SystemIZI · Traditional | 08/28/1991SE |
Questions and answers
When was Quantix Cardiac Angiographic System cleared by the FDA?
Quantix Cardiac Angiographic System (K850455) received a 510(k) decision of Substantially Equivalent on May 6, 1985, 89 days after the submission was received.
What is the product code of K850455?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.