System, X-Ray, Tomographic
Regulation 892.1740
2510(k)s in 12 months (42 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in IZF
| 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 |
| Feb 10, 2020 | Agfa N.V. 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. Th Terminated |
IZF | K183275 |
| Sep 21, 2018 | Philips Electronics North America Corporation Cesar Powerpack-Visub(V3000), System Code 72243
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZF | K925302 |
| Sep 21, 2018 | Philips Electronics North America Corporation Cesar-DMCP-Visub(HM2000/3000), System Code 72239
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZF | K925302 |
| Sep 21, 2018 | Philips Electronics North America Corporation Poly C- DMCP-Visub(H3000), System Code 72238
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZF | K925302 |
| Jul 10, 2003 | Siemens Medical Solutions USA, Inc 3D Ceiling Suspension Terminated |
IZF | K790765 K803130 |
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