FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K Number: K081963
·
Decision Jul 25, 2008
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
5
Review Days
15
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Basic Information
- Device Name
- AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
- K Number
- K081963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agfa Healthcare Corporation
- Date Received
- July 10, 2008
- Decision Date
- July 25, 2008
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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Other Clearances by Agfa Healthcare Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | Jul 28, 2008 | Substantially Equivalent |
| K080013 | REGISTRATION AND FUSION | Jan 17, 2008 | Substantially Equivalent |
| K073271 | ORTHOGON | Dec 5, 2007 | Substantially Equivalent |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | Oct 25, 2007 | Substantially Equivalent |