FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K Number: K993597
·
Decision Dec 15, 1999
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
60
Applicant Total
13
Review Days
51
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Basic Information
- Device Name
- PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
- K Number
- K993597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2030
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vidar Systems Corp.
- Date Received
- October 25, 1999
- Decision Date
- December 15, 1999
- Product Code
- LMA
- 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 |
|---|---|---|---|
| LMA | Digitizer, Image, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMA), ordered by most recent decision date.
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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 |
| K024171 | VIDAR BONE TRACK SYSTEM SOFTWARE | Mar 4, 2003 | 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 |