FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
DR 800 with Tomosynthesis
K Number: K183275
·
Decision Feb 1, 2019
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
6
Review Days
70
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Basic Information
- Device Name
- DR 800 with Tomosynthesis
- K Number
- K183275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agfa N.V.
- Date Received
- November 23, 2018
- Decision Date
- February 1, 2019
- Product Code
- IZF
- 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 |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | FDA class 2 | Radiology |
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Other Clearances by Agfa N.V.
| K Number | Device Name | ||
|---|---|---|---|
| K213469 | VALORY | Nov 18, 2021 | Substantially Equivalent |
| K212145 | DR 800 with DSA, DR 800 | Aug 31, 2021 | Substantially Equivalent |
| K211790 | DX-D Imaging Package with XD Detectors | Jul 30, 2021 | Substantially Equivalent |
| K193262 | DR 600 with Tomosynthesis | Mar 9, 2020 | Substantially Equivalent |
| K191884 | DR 100s | Aug 9, 2019 | Substantially Equivalent |