Affera™ Mapping System
The Affera Mapping System displays the position of compatible cardiac catheters and creates maps for electrophysiology procedures. It can record and display patient signals, including…
The Affera Mapping System displays the position of compatible cardiac catheters and creates maps for electrophysiology procedures. It can record and display patient signals, including intracardiac electrograms, and supports pacing. The mapping workstation presents catheter locations and cardiac maps in several formats.
A magnetic field generator beneath the procedure table works with passive sensors embedded in the catheters. The system calculates their locations to provide real time tracking. It connects with electrophysiology recording equipment and external stimulators, and can display ablation data when used with the compatible Affera ablation system.
Listed Item
Mapping System AFR-00003 US
Mapping Outputs
Available map types include geometric, voltage, activation and propagation maps. The system also supports internally generated pacing signals as well as externally generated pacing. These functions depend on compatible connected catheters and equipment.
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K233943 |
| Record published | 2024-10-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature -10 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AFR-00003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| Computer, Diagnostic, Programmable | St. Jude Medical | 57 |
| MediGuide™ | St. Jude Medical | 41 |
| AcQMap | Acutus Medical, Inc. | 38 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 28 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262005 | 2026-08-21 |
| K243892 | 2025-01-17 |
| K243435 | 2024-12-05 |
| K241828 | 2024-11-01 |
| K233943 | 2024-03-08 |
| K181918 | 2018-11-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.