FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Prelude
K Number: K180308
·
Decision Mar 27, 2018
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
11
Review Days
53
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Basic Information
- Device Name
- Prelude
- K Number
- K180308
- 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
- February 2, 2018
- Decision Date
- March 27, 2018
- Product Code
- MUJ
- 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 |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
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|---|---|---|---|
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| 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 |
| K092653 | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 | Sep 18, 2009 | 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 |