FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VERISUITE 1.6, VERISUITE-PARTICLE 1.6
K Number: K080742
·
Decision May 9, 2008
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
11
Review Days
53
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Basic Information
- Device Name
- VERISUITE 1.6, VERISUITE-PARTICLE 1.6
- K Number
- K080742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcom GmbH
- Date Received
- March 17, 2008
- Decision Date
- May 9, 2008
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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| K133914 | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE | Apr 3, 2014 | Substantially Equivalent |
| K102237 | PVS MODEL 1.0 | Nov 23, 2010 | Substantially Equivalent |
| K100056 | MEDCOM RT-VIEWER SYSTEM | May 7, 2010 | Substantially Equivalent |
| K092653 | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 | Sep 18, 2009 | Substantially Equivalent |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Sep 25, 2003 | Substantially Equivalent |
| K022219 | EXOMIO, MODEL 1.1 | Oct 7, 2002 | Substantially Equivalent |