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510(k) K223918

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub by Philips Medical Systems Nederland B.V. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2023
Date Received
December 29, 2022
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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  • K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea (January 14, 2026)
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  • K251215 — Philips IntelliSpace Cardiovascular (October 2, 2025)
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  • K251808 — Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; I (July 11, 2025)
  • K250648 — Philips iCT CT system (June 27, 2025)

Other clearances for product code DQK

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  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)