FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAR BONE TRACK SYSTEM SOFTWARE
K Number: K024171
·
Decision Mar 4, 2003
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
13
Review Days
76
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Basic Information
- Device Name
- VIDAR BONE TRACK SYSTEM SOFTWARE
- K Number
- K024171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vidar Systems Corp.
- Date Received
- December 18, 2002
- Decision Date
- March 4, 2003
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by Vidar Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130636 | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | Jun 7, 2013 | Substantially Equivalent |
| K130406 | DIAGNOSTICPRO EDGE | Apr 29, 2013 | Substantially Equivalent |
| K102476 | TELERADPRO | Oct 7, 2010 | Substantially Equivalent |
| K093809 | VIDAR DENTAL FILM DIGITIZER | Jan 7, 2010 | Substantially Equivalent |
| K071193 | VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS | May 30, 2007 | Substantially Equivalent |
| K070563 | VIDAR VISION 2000 | Mar 16, 2007 | Substantially Equivalent |
| K011049 | EXPRESSSUITE | Oct 1, 2001 | Substantially Equivalent |
| K993598 | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 | Jan 20, 2000 | Substantially Equivalent |
| K993599 | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 | Jan 18, 2000 | Substantially Equivalent |
| K993597 | PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 | Dec 15, 1999 | Substantially Equivalent |