510(k) K253861
- Device
- ACORYS MAPPING SYSTEM
- Applicant
- Corify Care S.L
- 510(k) number
- K253861
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-13
- Date received
- 2025-12-03
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Javier Milagro
- Address
- C/ Doctor Castelo 44- Bajo Izq. Madrid ES 28009 28009
FDA Registration Numbers
- 2184149
- 3005877899
- 9710602
- 1218950
- 3007603855
- 3032109181
- 3013627970
- 3001592626
- 1054713
- 3004972322
- 3010342616
- 3012811961
- 2183744
- 3016701404
- 3006087789
- 3009077524
- 3017401510
- 2134265
- 3009092139
- 3012268816
- 3017060084
- 3014271754
- 2183715
- 3012520654
- 3018783526
- 3010390468
- 3013557562
- 2024168
- 9617277
- 2246552
- 2133772
- 1319660
- 2031044
- 3022780114
- 3021016555
- 3030125003
- 2183926
- 3007770164
- 3007184699
- 1064858
- 3017233611
- 2126666
- 3018940143
- 3017840980
- 1018233
- 9615102
- 3003084417
- 3005334138
- 3017638059
- 3010157426
- 3000279201
- 3009254201
- 3020036682
- 3016406615
- 3007734888
- 3008729547
- 3030721635
- 3013679558
- 1058584
- 3016618143
- 9615817
- 3015151147
- 3010705768
- 3002672225
- 3007603826
- 3003768277
- 3013300026
- 3014848734
- 3012528160
- 3022451073
- 3000976525
- 3014128039
- 3008363989
- 1928237
- 3033959233
- 3004016520
- 2133641
- 9611295
- 3004091615
- 3008159616
- 3001570235
- 3004594159
- 3003144120
- 3004006614
- 3004415095
- 3023164
- 3013403214
- 9610816
- 3012260771
- 9673241
- 3008329188
- 3013581838
- 9616760
- 3004105270
- 3010728615
- 3000126629
- 3011353843
- 3003971136
- 9610105
- 3009443693
- 3019388613
- 3010716438
- 3007208829
- 8022257
- 3031786139
- 1930027
- 3026523691
- 3005210579
- 2032112
- 3012027770
- 2133810
- 3010273872
- 2438852
- 3004977335
- 1650907
- 1219324
- 3003616071
- 3013596024
- 3023272766
- 3043479346
- 3008093809
- 2182208
- 3012619193
- 1721686
- 3017684005
- 3042175841
- 2029275
- 1651104
- 3012154226
- 3024821700
- 1000122786
- 1317188
- 2124215
- 3008012314
- 2952596
- 3012179728
- 3001763079
- 8030978
- 2135338
- 3007029079
- 3008203003
- 3014272734
- 1000165971
- 3008483389
- 2183164
- 3013500228
- 1316463
- 2015691
- 1224919
- 3016674095
- 3021769057
- 2648045
- 3010089768
- 2030404
- 3009499478
- 3008717264
- 3010288146
- 3016678045
- 3012032144
- 3017845286
- 3012359877
- 3010155648
- 3006082230
- 3009715978
- 3013943846
- 3009831876
- 1527715
- 3026740087
- 3032916632
- 3008452825
- 3022435840
- 2134213
- 1320894
- 3009600098
- 3012552532
- 3037724692
- 3033558564
- 9681377
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DQK
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260212 | EnSite X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
| K252972 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 |
| K254089 | IOPS Visionary System (MC-3); 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, Inc. | 2026-02-17 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026-02-06 |
| K252164 | NorthStar Mapping System | Imricor Medical Systems | 2026-01-28 |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026-01-18 |
| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | 2025-12-19 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025-10-24 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2025-10-24 |