FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RT DESKTOP
K Number: K982713
·
Decision Nov 2, 1998
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- RT DESKTOP
- K Number
- K982713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Oncology Systems, Ltd.
- Date Received
- August 4, 1998
- Decision Date
- November 2, 1998
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Elekta Oncology Systems, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K032996 | ELEKTA SYNERGY SYSTEM | Oct 23, 2003 | Substantially Equivalent |
| K012289 | MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) | Aug 14, 2001 | Substantially Equivalent |
| K981790 | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW | Aug 7, 1998 | Substantially Equivalent |