FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
K Number: K092653
·
Decision Sep 18, 2009
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
11
Review Days
21
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Basic Information
- Device Name
- VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
- K Number
- K092653
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcom GmbH
- Date Received
- August 28, 2009
- Decision Date
- September 18, 2009
- Product Code
- LHN
- 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 |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
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Other Clearances by Medcom GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K181789 | VeriSuite | Sep 21, 2018 | Substantially Equivalent |
| K180308 | Prelude | Mar 27, 2018 | Substantially Equivalent |
| K170841 | BiopSee, Mobile US | Jul 26, 2017 | Substantially Equivalent |
| K163119 | NaviSuite SSI Edition | May 1, 2017 | Substantially Equivalent |
| 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 |
| K080742 | VERISUITE 1.6, VERISUITE-PARTICLE 1.6 | May 9, 2008 | Substantially Equivalent |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Sep 25, 2003 | Substantially Equivalent |
| K022219 | EXOMIO, MODEL 1.1 | Oct 7, 2002 | Substantially Equivalent |