FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
DigiX FDX
K Number: K223060
·
Decision Oct 26, 2022
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
8
Review Days
26
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Basic Information
- Device Name
- DigiX FDX
- K Number
- K223060
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allengers Medical Systems Limited
- Date Received
- September 30, 2022
- Decision Date
- October 26, 2022
- 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 Allengers Medical Systems Limited
| K Number | Device Name | ||
|---|---|---|---|
| K253296 | Digital C-ARM with 3D | Jun 5, 2026 | Substantially Equivalent |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Apr 18, 2025 | Substantially Equivalent |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Nov 27, 2022 | Substantially Equivalent |
| K220311 | Cardiovascular Angiography System | May 3, 2022 | Substantially Equivalent |
| K200218 | Digiscan FDX | Jul 13, 2020 | Substantially Equivalent |
| K192541 | DigiX FDX | Oct 16, 2019 | Substantially Equivalent |
| K162529 | DigiX FDX | Mar 3, 2017 | Substantially Equivalent |