"An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to
| Company | Devices | Share |
|---|---|---|
| St. Jude Medical, Inc. | 109 | 93% |
| Catheter Precision, Inc. | 3 | 3% |
| Mycardium Ai Limited | 1 | 1% |
| Rhythm Ai Inc. | 1 | 1% |
| Ventric Health | 1 | 1% |
| Cardionxt Inc | 1 | 1% |
| O&M Halyard, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| DQK | Computer, diagnostic, programmable | 82 |
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 27 |
| DQK | Computer, Diagnostic, Programmable | 7 |
| QIH | Automated Radiological Image Processing Software | 1 |
| QUO | Adjunctive Heart Failure Status Indicator | 1 |
| PUI | Drape, surgical, exempt | 1 |
Use these as the dimensions to specify in a tender line.
117 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac mapping system application software", from 7 companies. The largest labeler is St. Jude Medical, Inc. with 93% of records.
DQK (Computer, diagnostic, programmable), DQK (COMPUTER, DIAGNOSTIC, PROGRAMMABLE), DQK (Computer, Diagnostic, Programmable), 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.