510(k) Report

FDA applicant

Philips Medical Systems North America, Inc.

Shelton, CT95 decisions1989–2010309 recalls

FDA records 95 decisions for Philips Medical Systems North America, Inc. (Shelton, CT) from 1989 to 2010: 95 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and LLZ (System, Image Processing, Radiological). Its devices cite 110 predicates, 27 of them its own earlier devices. 309 recalls are linked to its devices, 19 Class I.

FDA’s records also spell it “Philips Medical Systems North America Co.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Philips Medical Systems North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2007: 12008: 12009: 22010: 2
2007high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

7in 2026

2007: 122008: 222009: 42010: 92011: 22012: 92013: 52014: 122015: 292016: 62017: 7, 2 Class I2018: 792019: 72020: 22023: 5, 1 Class I2024: 7, 3 Class I2025: 61, 13 Class I2026 (partial year): 7
2007high 79 (2018) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Philips Medical Systems North America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Medical Systems North America…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging19decisions
  • LLZSystem, Image Processing, Radiological16decisions
  • JAKSystem, X-Ray, Tomography, Computed10decisions
  • IZISystem, X-Ray, Angiographic9decisions
  • OWBInterventional Fluoroscopic X-Ray System5decisions
  • KPRSystem, X-Ray, Stationary4decisions

Also: JAA (4), MHX (3), MOS (3), IZL (2), IYE (2), IZH (2).

Whose devices does it build on?

Its devices cite 110 predicates; 27 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 156 times; 27 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 200620cite it
  • K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 200618cite it
  • K984545Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) SystemsPhilips Medical Systems North America, Inc. · 19998cite it
  • K090625Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 20097cite it
  • K061995XceleraPhilips Medical Systems North America Co. · 20067cite it
  • K040254Integris 3D-RA, Release 4.2Philips Medical Systems North America Co. · 20046cite it

What has FDA decided for it lately?

  • K101311EP Navigator R3Philips Medical Systems North America Co. · 2010
  • K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 201039 recalls
  • K090625Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 200928 recalls
  • K090590Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
  • K082280Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs MonitorPhilips Medical Systems North America Co. · 2008
  • K063781Philips XD-S Direct Radiography Workstation/PackagePhilips Medical Systems North America Co. · 20071 recall
  • K062233Heartstart MRX Monitor/DefibrillatorPhilips Medical Systems North America, Inc. · 20062 Class I recalls
  • K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co. · 2006

All 71 as Philips Medical Systems North America, Inc. →All 24 as Philips Medical Systems North America Co. →

What has been recalled?

309 recalls linked to its devices; the latest:

  • K030520Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T…Aug 21, 2026Class II
  • K102005Philips Allura under the following System Descriptions and corresponding model numbers…Jun 17, 2026Class II
  • K102005Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional…Jun 17, 2026Class II
  • K023441Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for…May 18, 2026Class II
  • K102005Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper…May 18, 2026Class II
  • K102005Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003…Apr 30, 2026Class II