FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
LEKSELL GAMMAPLAN
K Number: K061540
·
Decision Jul 5, 2006
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
47
Applicant Total
30
Review Days
30
Basic Information
- Device Name
- LEKSELL GAMMAPLAN
- K Number
- K061540
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ELEKTA INSTRUMENT AB
- Date Received
- June 5, 2006
- Decision Date
- July 5, 2006
- Product Code
- IWB
- 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 |
|---|---|---|---|
| IWB | System, Radiation Therapy, Radionuclide | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | Mar 2, 2016 | Substantially Equivalent |
| K151159 | Leksell Gamma Knife Perfexion | Oct 29, 2015 | Substantially Equivalent |
| K151666 | Leksell GammaPlan | Sep 3, 2015 | Substantially Equivalent |
| K151561 | Leksell Gamma Knife Icon | Aug 4, 2015 | Substantially Equivalent |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | May 9, 2014 | Substantially Equivalent |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | May 24, 2012 | Substantially Equivalent |
| K103093 | LEKSELL GAMMAPLAN | Dec 21, 2010 | Substantially Equivalent |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | Sep 22, 2009 | Substantially Equivalent |
| K090972 | LEKSELL GAMMAPLAN | Jul 20, 2009 | Substantially Equivalent |
| K080355 | LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS | May 1, 2009 | Substantially Equivalent |