FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K Number: K081976
·
Decision Jul 28, 2008
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
17
Basic Information
- Device Name
- IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
- K Number
- K081976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AGFA HEALTHCARE CORPORATION
- Date Received
- July 11, 2008
- Decision Date
- July 28, 2008
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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Other Clearances by AGFA HEALTHCARE CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS | Jul 25, 2008 | Substantially Equivalent |
| K080013 | REGISTRATION AND FUSION | Jan 17, 2008 | Substantially Equivalent |
| K073271 | ORTHOGON | Dec 5, 2007 | Substantially Equivalent |
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