FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
K Number: K082510
·
Decision Oct 1, 2008
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
18
Review Days
33
Basic Information
- Device Name
- IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
- K Number
- K082510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TOMTEC IMAGING SYSTEMS, GMBH
- Date Received
- August 29, 2008
- Decision Date
- October 1, 2008
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by TOMTEC IMAGING SYSTEMS, GMBH
| K Number | Device Name | ||
|---|---|---|---|
| K150122 | TOMTEC-ARENA TTA2 | Feb 13, 2015 | Substantially Equivalent |
| K132544 | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA | Nov 25, 2013 | Substantially Equivalent |
| K120135 | 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 | Apr 13, 2012 | Substantially Equivalent |
| K110746 | 4D LV-ANALYSIS 3.0 | May 24, 2011 | Substantially Equivalent |
| K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | Apr 8, 2011 | Substantially Equivalent |
| K110595 | 4D SONO-SCAN 1.0 | Apr 7, 2011 | Substantially Equivalent |
| K103782 | 4D MV-ASSESSMENT 2.0 | Jan 27, 2011 | Substantially Equivalent |
| K090461 | IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 | May 22, 2009 | Substantially Equivalent |
| K083348 | IMAGE-ARENA APPLICATIONS | Dec 23, 2008 | Substantially Equivalent |
| K071232 | IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS | Jun 20, 2007 | Substantially Equivalent |