Philips Medical Systems Nethrlands BV: FDA filings under this applicant name

FDA lists 5 510(k) clearances under the applicant name “Philips Medical Systems Nethrlands BV” (first 2014, latest 2016), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Philips, based on public ownership records.

510(k) clearances per year

Top product codes

Review panels

• Radiology (5)

Most recent Philips Medical Systems Nethrlands BV 510(k) clearances

Recalls

openFDA lists no recalls under a recalling firm named Philips Medical Systems Nethrlands BV.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Philips Medical Systems Nethrlands BV (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 LNH)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Philips Medical Systems, Inc. (218 510(k)s)
• Philips Medical Systems (Cleveland), Inc. (190 510(k)s)
• Philips Medical Systems Nederland B.V. (106 510(k)s)
• Philips Medical Systems North America, Inc. (95 510(k)s)
• Philips Ultrasound, Inc. (77 510(k)s)
• Philips Medizin Systeme Boeblingen GmbH (48 510(k)s)
• Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (25 510(k)s)
• Philips Health Care (20 510(k)s)
• Philips Hearing Instruments Co. (20 510(k)s)
• Philips Medical Systems Dmc GmbH (18 510(k)s)
• Philips Healthcare (Suzhou) Co., Ltd. (17 510(k)s)
• Philips Medizin Systeme Boblingen GmbH (12 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Philips Medical Systems Nethrlands BV?

FDA lists 5 510(k) clearances under the applicant name “Philips Medical Systems Nethrlands BV” (first 2014, latest 2016), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Philips Medical Systems Nethrlands BV?

The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Medical Systems Nethrlands BV is 114 days.

Which FDA product codes appear under Philips Medical Systems Nethrlands BV?

The most frequent FDA product codes under this applicant name are OWB (Interventional Fluoroscopic X-Ray System, 2); JAK (System, X-Ray, Tomography, Computed, 1); LLZ (System, Image Processing, Radiological, 1).

Next steps

• See all 5 Philips Medical Systems Nethrlands BV clearances with predicates and recalls
• Run predicate analysis for product code OWB, Philips Medical Systems Nethrlands BV's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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