FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA RADIONICS XKNIFE RT 4
K Number: K061893
·
Decision Jul 25, 2006
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
10
Review Days
22
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Basic Information
- Device Name
- INTEGRA RADIONICS XKNIFE RT 4
- K Number
- K061893
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra Radionics, Inc.
- Date Received
- July 3, 2006
- Decision Date
- July 25, 2006
- Product Code
- MUJ
- 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 |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
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Other Clearances by Integra Radionics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102258 | CUSA NXT EXTENDED LENGTH TIP | Jun 10, 2011 | Substantially Equivalent |
| K100096 | LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART | Apr 22, 2010 | Substantially Equivalent |
| K100417 | XKNIFE 5 | Apr 8, 2010 | Substantially Equivalent |
| K090864 | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | May 8, 2009 | Substantially Equivalent |
| K083414 | RADIONICS XKNIFE HDRT SYSTEM | Mar 2, 2009 | Substantially Equivalent |
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM | Aug 13, 2008 | Substantially Equivalent |
| K072454 | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS | Oct 16, 2007 | Substantially Equivalent |
| K071669 | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP | Aug 17, 2007 | Substantially Equivalent |
| K063230 | INTEGRA RADIONICS IMAGEFUSION 3 | Dec 21, 2006 | Substantially Equivalent |