FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
K Number: K091628
·
Decision Aug 21, 2009
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
82
Applicant Total
2
Review Days
78
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Basic Information
- Device Name
- OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
- K Number
- K091628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Protec GmbH & Co. KG
- Date Received
- June 4, 2009
- Decision Date
- August 21, 2009
- 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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Other Clearances by Protec GmbH & Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K992818 | OPTIMAX/ COMPACT 2 | Sep 1, 1999 | Substantially Equivalent |