Philips Medical Systems North America, Inc.: FDA clearances and approvals
Philips Medical Systems North America, Inc. has 95 FDA 510(k) clearances (first 1989, latest 2010), across 28 product codes in 3 review panels. Median 510(k) review time: 63 days. openFDA lists 5 product recalls by a recalling firm named Philips Medical Systems North America, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 19 | 19 |
| LLZ | System, Image Processing, Radiological | 16 | 16 |
| JAK | System, X-Ray, Tomography, Computed | 10 | 10 |
| IZI | System, X-Ray, Angiographic | 9 | 9 |
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 4 | 4 |
| KPR | System, X-Ray, Stationary | 4 | 4 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 | 3 |
| MOS | Coil, Magnetic Resonance, Specialty | 3 | 3 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
Plus 18 more product codes.
Review panels
- Radiology (89)
- Cardiovascular (5)
- Anesthesiology (1)
Most recent Philips Medical Systems North America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101311 | EP NAVIGATOR R3 | LLZ | 2010-09-30 | 142 |
| K102005 | ALLURA XPER OR TABLE SERIES | OWB | 2010-08-09 | 25 |
| K090625 | WIRELESS PORTABLE DETECTOR FD-W17 | MQB | 2009-03-24 | 15 |
| K090590 | VERADIUS, MODEL 718-130 | OWB | 2009-03-16 | 12 |
| K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | MHX | 2008-10-08 | 58 |
| K063781 | PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE | LLZ | 2007-01-05 | 15 |
| K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR | MKJ | 2006-11-22 | 112 |
| K062268 | MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 | DQA | 2006-10-18 | 72 |
| K062283 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS | MHX | 2006-09-20 | 44 |
| K061685 | PULSERA | IZL | 2006-09-15 | 92 |
85 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2014-02-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Philips Medical Systems North America, Inc.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Philips Medical Systems North America, Inc. have?
Philips Medical Systems North America, Inc. has 95 FDA 510(k) clearances (first 1989, latest 2010), across 28 product codes in 3 review panels.
How long does FDA take to clear Philips Medical Systems North America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Philips Medical Systems North America, Inc.'s cleared 510(k)s is 63 days.
What devices does Philips Medical Systems North America, Inc. make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 19); LLZ (System, Image Processing, Radiological, 16); JAK (System, X-Ray, Tomography, Computed, 10).
Has Philips Medical Systems North America, Inc. had device recalls?
openFDA lists 5 product recalls in 4 recall events by a recalling firm whose name matches Philips Medical Systems North America, Inc; the most recent began 2014-02-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 95 Philips Medical Systems North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Philips Medical Systems North America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.