FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAASTRO Rectal Applicator Set
K Number: K252717
·
Decision May 20, 2026
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
33
Review Days
265
Basic Information
- Device Name
- MAASTRO Rectal Applicator Set
- K Number
- K252717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Varian Medical Systems
- Date Received
- August 28, 2025
- Decision Date
- May 20, 2026
- Product Code
- JAQ
- 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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Other Clearances by Varian Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K252884 | Guided Aarhus Applicator Set | Nov 19, 2025 | Substantially Equivalent |
| K250099 | Mobius3D (4.1) | May 16, 2025 | Substantially Equivalent |
| K250289 | Intracavitary/Interstitial System | Apr 25, 2025 | Substantially Equivalent |
| K242378 | Eclipse Treatment Planning System (18.1) | Dec 11, 2024 | Substantially Equivalent |
| K242961 | Intraluminal Applicator Set | Nov 26, 2024 | Substantially Equivalent |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Oct 29, 2024 | Substantially Equivalent |
| K241876 | Vitesse (5.0) | Oct 23, 2024 | Substantially Equivalent |
| K232400 | VariSeed (v10) | Sep 8, 2023 | Substantially Equivalent |
| K133191 | PROBEAM PROTON THERAPY SYSTEM | Jan 10, 2014 | Substantially Equivalent |
| K124002 | VERIFICATION CONSOLE | Feb 21, 2013 | Substantially Equivalent |