DX-D 100— 510(k) K103597
Substantially EquivalentAgfa Healthcare N.V.
FDA 510(k) clearance K103597 for DX-D 100, Substantially Equivalent on 2011-01-03. Applicant: Agfa Healthcare N.V.. Device class: 2.
Clearance details
- Applicant
- Agfa Healthcare N.V.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenville, SC, US
Recent devices under product code IZL
view allMore clearances from Agfa Healthcare N.V.
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K103597
K-number listed on FDA's recall record- Z-1462-2024 — Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400
- Z-1698-2017 — AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
- Z-1745-2015 — AGFA DX-D 100 is a mobile digital radiography x-ray system
- Z-2081-2014 — AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.
- Z-2176-2014 — Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
- Z-1487-2013 — AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103597.
Data sourced from openFDA. This site is unofficial and independent of the FDA.