DR 800 with Tomosynthesis— 510(k) K183275
Substantially EquivalentAgfa N.V.
FDA 510(k) clearance K183275 for DR 800 with Tomosynthesis, Substantially Equivalent on 2019-02-01. Applicant: Agfa N.V.. Device class: 2.
Clearance details
- Applicant
- Agfa N.V.
- Product code
- Code IZF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1740
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mortsel, BE
Recent devices under product code IZF
view allMore clearances from Agfa N.V.
view allRecalls naming K183275
K-number listed on FDA's recall record- Z-0923-2026 — Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
- Z-2738-2024 — DR 800. Digital Radiography X-ray System.
- Z-1502-2020 — AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183275.
Data sourced from openFDA. This site is unofficial and independent of the FDA.