FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Elekta Unity
K Number: K223209
·
Decision Feb 23, 2023
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
14
Review Days
129
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Basic Information
- Device Name
- Elekta Unity
- K Number
- K223209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Solutions AB
- Date Received
- October 17, 2022
- Decision Date
- February 23, 2023
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Elekta Solutions AB
| K Number | Device Name | ||
|---|---|---|---|
| K252002 | Monaco RTP System (6.3) | Feb 19, 2026 | Substantially Equivalent |
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| K251363 | ProKnow DS | Oct 8, 2025 | Substantially Equivalent |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Jul 2, 2025 | Substantially Equivalent |
| K232854 | Leksell GammaPlan (LGP) | Feb 8, 2024 | Substantially Equivalent |
| K223229 | MOSAIQ® OIS (Oncology Information System) | Feb 23, 2023 | Substantially Equivalent |
| K223233 | Monaco RTP System | Feb 23, 2023 | Substantially Equivalent |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Oct 26, 2022 | Substantially Equivalent |
| K213787 | Monaco RTP System | May 17, 2022 | Substantially Equivalent |
| K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | Oct 25, 2021 | Substantially Equivalent |