FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AcuityDRe
K Number: K210919
·
Decision Apr 30, 2021
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
6
Review Days
32
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Basic Information
- Device Name
- AcuityDRe
- K Number
- K210919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radmedix, LLC
- Date Received
- March 29, 2021
- Decision Date
- April 30, 2021
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 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 |
| 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 |