FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
K Number: K013531
·
Decision Nov 7, 2001
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
13
Review Days
15
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Basic Information
- Device Name
- QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
- K Number
- K013531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Impac Medical Systems, Inc.
- Date Received
- October 23, 2001
- Decision Date
- November 7, 2001
- Product Code
- KPQ
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Impac Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151233 | Monaco | Jul 7, 2015 | Substantially Equivalent |
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Sep 5, 2014 | Substantially Equivalent |
| K132971 | MONACO | Nov 20, 2013 | Substantially Equivalent |
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Dec 12, 2012 | Substantially Equivalent |
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Feb 28, 2012 | Substantially Equivalent |
| K043412 | MODIFICATION TO: VIEWSTATION | Dec 20, 2004 | Substantially Equivalent |
| K011694 | VIEWSTATION | Aug 29, 2001 | Substantially Equivalent |
| K991133 | MLC FIT | Mar 27, 2000 | Substantially Equivalent |
| K981313 | SEQUENCER | Jul 9, 1998 | Substantially Equivalent |
| K962335 | MLC FIT | Feb 6, 1997 | Substantially Equivalent |