FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
APEX
K Number: K111676
·
Decision Sep 30, 2011
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
50
Applicant Total
8
Review Days
107
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Basic Information
- Device Name
- APEX
- K Number
- K111676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Limited
- Date Received
- June 15, 2011
- Decision Date
- September 30, 2011
- Product Code
- IXI
- 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 |
|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | FDA class 2 | Radiology |
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