FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AcuityUDR
K Number: K231995
·
Decision Oct 25, 2023
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
6
Review Days
112
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Basic Information
- Device Name
- AcuityUDR
- K Number
- K231995
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radmedix, LLC
- Date Received
- July 5, 2023
- Decision Date
- October 25, 2023
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Radmedix, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Jul 12, 2023 | Substantially Equivalent |
| K210919 | AcuityDRe | Apr 30, 2021 | Substantially Equivalent |
| K201058 | Accuvue+ | May 6, 2020 | Substantially Equivalent |
| K200726 | AcuityPDR | Apr 13, 2020 | Substantially Equivalent |
| K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | Jan 2, 2020 | Substantially Equivalent |