3TP SOFTWARE OPTION
FDA 510(k) clearance K031350 · decided 2003-06-23
Clearance details
- K-number
- K031350
- Device name
- 3TP SOFTWARE OPTION
- Applicant
- 3tp, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-04-29
- Decision date
- 2003-06-23
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and recall (Z-0653-2009) | iCAD, Inc. | 2009-01-27 |