Company ยท US
AGFA Healthcare Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2008. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
15recalls (1 in 12 months)
12recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2008 | K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION Agfa Healthcare Corporation | LLZ |
| Jul 25, 2008 | K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS Agfa Healthcare Corporation | MQB |
| Jan 17, 2008 | K080013 | REGISTRATION AND FUSION Agfa Healthcare Corporation | LLZ |
| Dec 5, 2007 | K073271 | ORTHOGON Agfa Healthcare Corporation | LLZ |
| Oct 25, 2007 | K072680 | DRYSTAR AXYS, MODEL EYZ4E Agfa Healthcare Corporation | LMC |
| Jul 30, 2007 | K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS Agfa Healthcare Corp. | LLZ |
| Jun 22, 2007 | K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) Agfa Healthcare Corp. | LLZ |
| May 8, 2007 | K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS Agfa Healthcare Corp. | MQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2025 | AGFA Healthcare Corp. Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
Common Name: DR 800 Open, Classified |
IZF | K183275 |
| Oct 10, 2024 | Agfa Healthcare NV Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data .
Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8. Open, Classified |
LLZ | K170434 |
| Jan 20, 2023 | Agfa Healthcare NV Agfa HealthCare Enterprise Imaging XERO Viewer Open, Classified |
LLZ | K170434 |
| Aug 3, 2018 | Agfa Healthcare NV Enterprise Imaging Desktops
Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for Terminated |
LLZ | K111945 |
| Apr 5, 2017 | AGFA Healthcare Corp. DX-D600 - DXD Imaging Package Terminated |
KPR | K112670 |
| Mar 29, 2017 | AGFA Healthcare Corp. 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 Terminated |
IZL | K103597 |
| Dec 22, 2016 | AGFA Healthcare Corp. IMPAX Cardiovascular
The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with rep Terminated |
LLZ | K050228 |
| Dec 21, 2016 | AGFA Healthcare Corp. Agfa Healthcare NX 3.0.8950 Imaging Processing Software Terminated |
MQB | K090672 |
| Sep 1, 2015 | AGFA Healthcare Corp. IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Numbe Terminated |
LLZ | K050228 |
| Jul 13, 2015 | AGFA Healthcare Corp. IMPAX Agility.
IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, rev Terminated |
LLZ | None listed |
| Jun 10, 2015 | AGFA Healthcare Corp. AGFA DX-D 100 is a mobile digital radiography x-ray system Terminated |
IZL | K103597 |
| Dec 16, 2014 | AGFA Healthcare Corp. Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM Terminated |
IWZ | None listed |
| Aug 10, 2014 | AGFA Healthcare Corp. Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Terminated |
IWZ | None listed |
| Aug 10, 2014 | AGFA Healthcare Corp. 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. Terminated |
IZL | K103597 |
| Aug 10, 2014 | AGFA Healthcare Corp. DX-D 600 - DXD Imaging Package
Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to crea Terminated |
KPR | K112670 |