510(k) K253463
- Device
- ILR ECG Analyzer (IM007)
- Applicant
- Implicity, Inc.
- 510(k) number
- K253463
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-02
- Date received
- 2025-10-08
- 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
- N
Applicant Contact#
- Contact
- Caroline Florequin
- Address
- 185 Alewife Brook Pkwy., Suite 210 Cambridge MA US 02138 02138
FDA Registration Numbers#
- 8022257
- 3013557562
- 3033959233
- 3014272734
- 3023164
- 3013679558
- 3010390468
- 3008093809
- 2134265
- 2032112
- 2031044
- 2182208
- 9681377
- 3014271754
- 3020036682
- 3032109181
- 3005334138
- 3001570235
- 3042175841
- 9710602
- 1721686
- 3009600098
- 3012268816
- 3022780114
- 3001763079
- 3004006614
- 3014848734
- 3030721635
- 9616760
- 2184149
- 2133772
- 3018783526
- 3010288146
- 1930027
- 1000122786
- 3015151147
- 2135338
- 2183715
- 3030125003
- 2183164
- 3017638059
- 3007184699
- 3016618143
- 3000976525
- 2246552
- 3017840980
- 3017401510
- 3009831876
- 3012552532
- 3002672225
- 2133810
- 3013943846
- 1054713
- 2648045
- 8030978
- 3008483389
- 3003617581
- 3014128039
- 3007603855
- 3032916632
- 3021016555
- 3004016520
- 3026523691
- 3024821700
- 3004415095
- 2952596
- 3007734888
- 3026740087
- 1650907
- 3012359877
- 1218950
- 3017684005
- 2126666
- 3013300026
- 3016406615
- 3043479346
- 3031786139
- 1224919
- 3045323923
- 3013596024
Source Documents#
Other 510(k) Records For Product Code DQK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | Centerline Biomedical | 2026-10-01 |
| 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 |
| 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 |