Home › Device types › JAK
System, X-Ray, Tomography, Computed
FDA product code JAK · Class 2 · Radiology
1,296
Registered devices
5,280
Adverse events
873
Recalls
826
510(k) clearances
Devices with this code
Somatom Force — Siemens Healthcare GmbHMonarch Software Laptop v2.1.6 — Auris Health, Inc.HealthOST — NANO-X AI LTDTABLE NL5000 FULL BODY PEDIATRIC (FBPT) — NEUROLOGICA CORP.EmpowerSync® Remote Control Pendant Switch — Bracco Injeneering SAuMI — Shanghai United Imaging Healthcare Co., Ltd.LODOX — LODOX SYSTEMS (PTY) LTDVISICOIL — Izi Medical Products, LLCRT — GE Hangwei Medical Systems Company Ltd.Gold Fiducial — Izi Medical Products, LLCAVIEW — CORELINE SOFT CO.,LTD.Extended Patient Introducer Mount — Auris Health, Inc.Monarch™ Laptop P17/P73 Linux USB Image v2.2.5 — Auris Health, Inc.NeuViz 128 Multi-slice CT Scanner System — Neusoft Medical Systems Co., Ltd.Monarch Endoscopy Platform (P1) System, Refurbished — Auris Health, Inc.InfinityLock™ — QfixARTIS icono floor — Siemens Healthcare GmbHVISICOIL — Izi Medical Products, LLCMonarch Software Cart v2.1.6 — Auris Health, Inc.830 to 870 DR Upgrade — G E MEDICAL SYSTEMS ISRAEL LTD.MAR — GE Healthcare Japan CorporationVISICOIL — Izi Medical Products, LLCImbio LDA — Imbio, LLCEncompass™ — Qfix
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | PHILIPS MEDICAL SYSTEMS | Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended s |
| 2026-08-18 | Philips North America Llc | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are m |
| 2026-08-07 | Philips North America Llc | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th |
| 2026-08-07 | Philips North America Llc | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th |
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