FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADC QS/IPD WORKSTATION
K Number: K010571
·
Decision Mar 28, 2001
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
19
Review Days
30
Basic Information
- Device Name
- ADC QS/IPD WORKSTATION
- K Number
- K010571
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AGFA CORP.
- Date Received
- February 26, 2001
- Decision Date
- March 28, 2001
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | Sep 24, 2003 | Substantially Equivalent |
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