FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CARDNAV
K Number: K120282
·
Decision Dec 10, 2012
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
8
Review Days
314
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Basic Information
- Device Name
- CARDNAV
- K Number
- K120282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paieon, Inc.
- Date Received
- January 31, 2012
- Decision Date
- December 10, 2012
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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Other Clearances by Paieon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113594 | C-THV SYSTEM | Mar 2, 2012 | Substantially Equivalent |
| K110256 | THE IC-PRO SYSTEM | May 27, 2011 | Substantially Equivalent |
| K083745 | THE IC-PRO SYSTEM, MODEL VERSION 3.2 | Feb 17, 2009 | Substantially Equivalent |
| K082907 | IC-PRO SYSTEM, VERSION 3.1.0.4 | Nov 18, 2008 | Substantially Equivalent |
| K073328 | CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA | Sep 9, 2008 | Substantially Equivalent |
| K072591 | CARDIOP-B SYSTEM, VERSION 2.1 | Oct 10, 2007 | Substantially Equivalent |
| K030139 | THE CARDIOP-B SYSTEM | Apr 2, 2004 | Substantially Equivalent |