FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRYSTAR AXYS, MODEL EYZ4E
K Number: K072680
·
Decision Oct 25, 2007
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
5
Review Days
31
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Basic Information
- Device Name
- DRYSTAR AXYS, MODEL EYZ4E
- K Number
- K072680
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agfa Healthcare Corporation
- Date Received
- September 24, 2007
- Decision Date
- October 25, 2007
- Product Code
- LMC
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | 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 |
| 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 |