510(k) K210822
- Device
- DeepRhythmAI
- Applicant
- Medicalgorithmics S.A.
- 510(k) number
- K210822
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-27
- Date received
- 2021-03-19
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Marek Dziubinski
- Address
- Aleje Jerozolimskie 81 Warsaw PL 02-001 02-001
FDA Registration Numbers#
- 2184149
- 1721686
- 3004006614
- 3042175841
- 8030978
- 3005210579
- 9611295
- 9610105
- 3033959233
- 3010157426
- 3022435840
- 1219324
- 2438852
- 2031044
- 3005877899
- 3012811961
- 3009715978
- 3003617581
- 3013403214
- 2246552
- 1928237
- 3006082230
- 2135338
- 3010390468
- 2133810
- 3023272766
- 3007734888
- 3016678045
- 3045891669
- 3010288146
- 3013679558
- 3017233611
- 3017401510
- 3017060084
- 2030404
- 3009092139
- 3003768277
- 1018233
- 3010716438
- 2183926
- 3006087789
- 3043479346
- 3001592626
- 3007184699
- 1058584
- 3008363989
- 3013596024
- 3045498928
- 3014128039
- 8022257
- 3014579161
- 3015151147
- 2024168
- 3022780114
- 2952596
- 9610816
- 3000126629
- 3007603855
- 3009254201
- 3017638059
- 3024821700
- 3001570235
- 3012027770
- 3008012314
- 3009600098
- 3000279201
- 1000165971
- 3008483389
- 1218950
- 3005334138
- 3014272734
- 1317188
- 2029275
- 9710602
- 3033558564
- 3010155648
- 3003084417
- 3012032144
- 3017684005
- 3013581838
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261729 | EnSite™ X EP System | Abbott Medical | 2026-09-17 |
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026-08-21 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | 2026-06-10 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 |
| K260212 | EnSite™ X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
Legacy Summary#
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FDA Review#
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