FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K Number: K081281
·
Decision May 20, 2008
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
19
Review Days
14
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Basic Information
- Device Name
- OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
- K Number
- K081281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nucletron Corporation
- Date Received
- May 6, 2008
- Decision Date
- May 20, 2008
- Product Code
- MUJ
- 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 |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
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Other Clearances by Nucletron Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K103515 | EQUAL DOSE | Sep 15, 2011 | Substantially Equivalent |
| K090706 | ONCENTRA SIMULATION 2.3 | Jun 15, 2009 | Substantially Equivalent |
| K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, | May 18, 2009 | Substantially Equivalent |
| K082642 | ONCENTRA RT VIEWER 1.0 | Nov 7, 2008 | Substantially Equivalent |
| K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET | May 28, 2008 | Substantially Equivalent |
| K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS | Apr 29, 2008 | Substantially Equivalent |
| K080929 | ONCENTRA GYN | Apr 16, 2008 | Substantially Equivalent |
| K073273 | EQUAL DOSE 1.0 | Dec 11, 2007 | Substantially Equivalent |
| K073107 | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 | Dec 7, 2007 | Substantially Equivalent |
| K061354 | MICROSELECTRON V3, MODEL 106.990 | Aug 17, 2006 | Substantially Equivalent |