Rhythmia HDx™
EGM Out to Signal Station Cable (Stockert™)
10manufacturers in China registered for this device type
26catalogue numbers in this listing
15510(k) clearances naming this product code
24recalls on this code
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 | Boston Scientific Corporation, 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-04-24 |
| Record revised | 2024-10-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M004RA64030 | In distribution | |
| M004RAMMTIPS220 | In distribution | |
| M004RH11220 | In distribution | |
| M004RH1020H0 | In distribution | |
| M004RA5010A0 | In distribution | |
| M004RH1020R0 | In distribution | |
| M004RALRCBL20 | In distribution | |
| M004RH14510 | In distribution | |
| M004RA60020 | In distribution | |
| M004RA9000ECG60 | In distribution | |
| M004RBEVAL2END0 | In distribution | |
| M004RA9000ICAB60 | In distribution | |
| M004RA61030 | In distribution | |
| M004RH20010 | In distribution | |
| M004RA9100ECG60 | In distribution | |
| M004RH20020 | In distribution | |
| M004RBINSTALL2EN0 | In distribution | |
| M004RH15010 | In distribution | |
| M004RH40100 | In distribution | |
| M004RA9100IC60 | In distribution | |
| M004RA9100ECG30 | In distribution | |
| M004RBINSTALL2ENR0 | In distribution | |
| M004RH10200 | In distribution | |
| M004RH11120 | In distribution | |
| M004RA9100IC30 | In distribution | |
| M004RA61020 | 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 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
| Pathfinder SL | Spacelabs Healthcare (Washington), Inc | 16 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253692 | 2026-08-21 |
| K251344 | 2025-05-28 |
| K241227 | 2024-08-29 |
| K230884 | 2023-09-26 |
| K212490 | 2021-10-20 |
| K210889 | 2021-06-25 |
| K201713 | 2020-07-23 |
| K201178 | 2020-05-29 |
| K192438 | 2019-11-27 |
| K191008 | 2019-07-02 |
| K173837 | 2018-07-25 |
| K162793 | 2017-03-10 |
| K151613 | 2015-10-06 |
| K141185 | 2014-06-06 |
| K003362 | 2001-03-01 |
Recalls
23 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 4 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 14 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 15 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 5 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 5 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 161 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 2 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 2 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 197 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 1 unit | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 5 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 1 unit | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 9 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 9 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 6 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 58 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 8 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 31 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 92 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 1 unit | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 124 units | |
| 2024-09-05 | Class II | Under Investigation by firm | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while | 40 units | |
| 2019-09-18 | Class II | Other | Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intend | 150 units | |
| 2005-03-14 | Not classified | Other | The device has the potential for overheating its transformer and has the potential for fire hazard. | 69 units distributed worldwide | 2005-12-13 |
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.