A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and
| Company | Devices | Share |
|---|---|---|
| Pie Medical Imaging B.V. | 48 | 8% |
| Icad, Inc. | 44 | 7% |
| Siemens Healthcare Gmbh | 40 | 7% |
| Imbio, Llc | 34 | 6% |
| Nobel Biocare Ab | 29 | 5% |
| Brit Systems, Llc | 16 | 3% |
| Perspectum Ltd | 16 | 3% |
| Quantib B.V. | 15 | 3% |
| Icometrix Nv | 13 | 2% |
| Nano-X Ai Ltd | 12 | 2% |
| Mevis Medical Solutions Ag | 11 | 2% |
| Philips Medical Systems Nederland B.V. | 11 | 2% |
Company = labeler of record on GUDID. 126 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 300 |
| LLZ | System, image processing, radiological | 98 |
| LMD | System, Digital Image Communications, Radiological | 66 |
| QIH | Automated Radiological Image Processing Software | 64 |
| JAK | System, X-Ray, Tomography, Computed | 44 |
| QAS | Radiological Computer-Assisted Triage And Notification Softw | 31 |
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587 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiology DICOM image processing application software", from 126 companies. The largest labeler is Pie Medical Imaging B.V. with 8% of records.
LLZ (System, Image Processing, Radiological), LLZ (System, image processing, radiological), LMD (System, Digital Image Communications, Radiological), QIH (Automated Radiological Image Processing Software)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.