FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K Number: K033374
·
Decision Nov 6, 2003
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
31
Review Days
15
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Basic Information
- Device Name
- LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
- K Number
- K033374
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens AG Medical Solutions
- Date Received
- October 22, 2003
- Decision Date
- November 6, 2003
- Product Code
- OEB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OEB | Lung Computed Tomography System, Computer-Aided Detection | FDA class 2 | Radiology |
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|---|---|---|---|
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| K123920 | SYNGO.VIA | Jan 18, 2013 | Substantially Equivalent |
| K120331 | SYNGO CT DYNAMIC ANGIO | Apr 13, 2012 | Substantially Equivalent |
| K111079 | SYNGO.VIA WEB VIEWER | May 13, 2011 | Substantially Equivalent |
| K101666 | SYNGO. PLAZA VA20A | Aug 10, 2010 | Substantially Equivalent |
| K100637 | SYNGO.CT CORONARY ANALYSIS | May 26, 2010 | Substantially Equivalent |
| K093612 | SYNGO.PLAZA | Mar 4, 2010 | Substantially Equivalent |
| K092067 | ABVS WORKPLACE | Sep 18, 2009 | Substantially Equivalent |
| K092519 | SYNGO.X | Aug 27, 2009 | Substantially Equivalent |