FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DR VISION NEO, DR VISION DOU
K Number: K080614
·
Decision Jun 20, 2008
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
5
Review Days
107
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Basic Information
- Device Name
- DR VISION NEO, DR VISION DOU
- K Number
- K080614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Almana Medical Imaging
- Date Received
- March 5, 2008
- Decision Date
- June 20, 2008
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Almana Medical Imaging
| K Number | Device Name | ||
|---|---|---|---|
| K100001 | MOBIVISION | Jun 25, 2010 | Substantially Equivalent |
| K082064 | RADVISION ET DIAGNOSTIC X-RAY SYSTEM | Aug 22, 2008 | Substantially Equivalent |
| K080847 | RFVISION, MODEL 9.9D | Aug 6, 2008 | Substantially Equivalent |
| K072659 | RAD VISION, MODELS E AND EU | Nov 15, 2007 | Substantially Equivalent |