FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
K Number: K052433
·
Decision Oct 18, 2005
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
26
Applicant Total
4
Review Days
42
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Basic Information
- Device Name
- PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
- K Number
- K052433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioptics, Inc.
- Date Received
- September 6, 2005
- Decision Date
- October 18, 2005
- Product Code
- MWP
- 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 |
|---|---|---|---|
| MWP | Cabinet, X-Ray System | FDA class 2 | Radiology |
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