FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AI Segmentation
K Number: K203469
·
Decision Apr 19, 2021
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
170
Review Days
145
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AI Segmentation
- K Number
- K203469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Varian Medical Systems, Inc.
- Date Received
- November 25, 2020
- Decision Date
- April 19, 2021
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUJ), ordered by most recent decision date.
RadOncAI
FDA 510(k)
FDA Class 2
·Radiology
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
FDA 510(k)
FDA Class 2
·Radiology
eXaSkin Plus
FDA 510(k)
FDA Class 2
·Radiology
ART.1-US
FDA 510(k)
FDA Class 2
·Radiology
syngo.via RT Image Suite VC10
FDA 510(k)
FDA Class 2
·Radiology
TrueFit Bolus
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Varian Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253026 | Respiratory Gating for Scanners (2.1) | Jun 4, 2026 | Substantially Equivalent |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Apr 23, 2026 | Substantially Equivalent |
| K252304 | syngo.via RT Image Suite VC10 | Mar 18, 2026 | Substantially Equivalent |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Jan 21, 2026 | Substantially Equivalent |
| K252919 | IDENTIFY (5.0) | Dec 16, 2025 | Substantially Equivalent |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Oct 7, 2025 | Substantially Equivalent |
| K250299 | CT/ MR Tandem and Ovoid Set | May 9, 2025 | Substantially Equivalent |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Mar 3, 2025 | Substantially Equivalent |
| K242957 | Identify (4.0) | Feb 7, 2025 | Substantially Equivalent |
| K242608 | Embozene Color-Advanced Microspheres | Jan 17, 2025 | Substantially Equivalent |