510(k) K180940
- Device
- KODEX EPD System
- Applicant
- Philips Medical Systems Nederland B.V.
- 510(k) number
- K180940
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-24
- Date received
- 2018-04-10
- 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
- Gina Crossetta
- Address
- Veenpluis 4-6 Pc Best NL 5684 5684
FDA Registration Numbers#
- 3005877899
- 1224919
- 3026523691
- 3031786139
- 3020036682
- 3023164
- 3013500228
- 1219324
- 3010390468
- 3017638059
- 3007770164
- 3002672225
- 1218950
- 3004415095
- 3012179728
- 3004977335
- 3024821700
- 3008717264
- 3003617581
- 3008729547
- 3004016520
- 3004972322
- 3032109181
- 3009499478
- 3008329188
- 3037724692
- 3030721635
- 3010716438
- 2133641
- 3033959233
- 2126666
- 3012528160
- 3004105270
- 3010089768
- 8022257
- 3006082230
- 2135338
- 3013581838
- 9710602
- 8030978
- 3017401510
- 3013596024
- 3010705768
- 3000976525
- 3017845286
- 3013943846
- 3008452825
- 3008159616
- 2030404
- 3018783526
- 3017684005
- 3005334138
- 1064858
- 9673241
- 9610105
- 3015151147
- 3016406615
- 3007734888
- 3021769057
- 2134213
- 2183164
- 3007208829
- 9617277
- 3008093809
- 3033558564
- 3011353843
- 3007137685
- 3012032144
- 3004091615
- 3016674095
- 3007603855
- 3014128039
- 3022780114
- 1000165971
- 3001570235
- 3026740087
- 1930027
- 3022435840
- 3003144120
- 3013557562
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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