FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K Number: K024342
·
Decision Apr 23, 2003
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
82
Applicant Total
1
Review Days
117
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Basic Information
- Device Name
- RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
- K Number
- K024342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Daito Co., Ltd.
- Date Received
- December 27, 2002
- Decision Date
- April 23, 2003
- Product Code
- IXW
- 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 |
|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | FDA class 2 | Radiology |
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