FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Qangio XA 3D
K Number: K182611
·
Decision May 30, 2019
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
6
Applicant Total
17
Review Days
251
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Basic Information
- Device Name
- Qangio XA 3D
- K Number
- K182611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medis Medical Imaging Systems BV
- Date Received
- September 21, 2018
- Decision Date
- May 30, 2019
- Product Code
- QHA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | FDA class 2 | Radiology |
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Other Clearances by Medis Medical Imaging Systems BV
| K Number | Device Name | ||
|---|---|---|---|
| K140587 | MR-CT VVA | Jan 6, 2015 | Substantially Equivalent |
| K112807 | X-RAY VVA | Feb 27, 2012 | Substantially Equivalent |
| K073156 | QPLAQUE MR | Mar 4, 2008 | Substantially Equivalent |
| K062386 | QANGIO CT | Oct 5, 2006 | Substantially Equivalent |
| K050703 | QBRAIN | Apr 21, 2005 | Substantially Equivalent |
| K042383 | RSA-CMS | Oct 20, 2004 | Substantially Equivalent |
| K041162 | ORTHO-CMS | Jul 27, 2004 | Substantially Equivalent |
| K040746 | MRA-CMS | Jun 8, 2004 | Substantially Equivalent |
| K033774 | CT-MASS | Mar 2, 2004 | Substantially Equivalent |
| K023970 | QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS | Jan 24, 2003 | Substantially Equivalent |