FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
MapRT
K Number: K243301
·
Decision May 19, 2025
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
7
Review Days
213
Basic Information
- Device Name
- MapRT
- K Number
- K243301
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vision RT Ltd
- Date Received
- October 18, 2024
- Decision Date
- May 19, 2025
- 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 Vision RT Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K233622 | AlignRT Plus | Mar 29, 2024 | Substantially Equivalent |
| K231185 | MapRT | Jun 23, 2023 | Substantially Equivalent |
| K212583 | AlignRT Plus | Nov 10, 2021 | Substantially Equivalent |
| K203387 | AlignRT Plus | Mar 4, 2021 | Substantially Equivalent |
| K193431 | AlignRT Plus | Jan 3, 2020 | Substantially Equivalent |
| K181218 | AlignRT Plus | Aug 7, 2018 | Substantially Equivalent |