FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILUMA VISION
K Number: K081347
·
Decision May 28, 2008
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
28
Review Days
14
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Basic Information
- Device Name
- ILUMA VISION
- K Number
- K081347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imtec Corp.
- Date Received
- May 14, 2008
- Decision Date
- May 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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|---|---|---|---|
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| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | Apr 23, 2003 | Substantially Equivalent |
| K024044 | SABER TECH IMPLANTS SYSTEM | Feb 21, 2003 | Substantially Equivalent |
| K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 | Dec 3, 2002 | Substantially Equivalent |