FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AcuityPDR
K Number: K200726
·
Decision Apr 13, 2020
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
6
Review Days
24
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Basic Information
- Device Name
- AcuityPDR
- K Number
- K200726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radmedix, LLC
- Date Received
- March 20, 2020
- Decision Date
- April 13, 2020
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by Radmedix, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K231995 | AcuityUDR | Oct 25, 2023 | Substantially Equivalent |
| 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 |
| K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | Jan 2, 2020 | Substantially Equivalent |