Philips Health Care: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Philips Health Care” (first 2011, latest 2020), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 40 days. Since 2017 the median was 43 days, against 120 days for all cleared 510(k)s in the same product codes. 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 100 |
| 2013 | 2 | 64 |
| 2014 | 0 | — |
| 2015 | 1 | 14 |
| 2016 | 3 | 20 |
| 2017 | 2 | 30 |
| 2018 | 0 | — |
| 2019 | 3 | 71 |
| 2020 | 3 | 51 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Philips Health Care took a median 43 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 7 |
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (17)
- Cardiovascular (3)
Most recent Philips Health Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201352 | 3D Auto LAA | LLZ | 2020-08-17 | 88 |
| K200974 | QLAB Advanced Quantification Software | QIH | 2020-06-03 | 51 |
| K200179 | Collaboration Live | LLZ | 2020-02-18 | 25 |
| K191647 | QLAB Advanced Quantification Software | QIH | 2019-12-20 | 183 |
| K192226 | Lumify Diagnostic Ultrasound System | IYN | 2019-09-06 | 21 |
| K190913 | QLAB Advanced Quantification Software 13 | LLZ | 2019-06-18 | 71 |
| K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | 2017-10-04 | 35 |
| K171314 | QLAB Advanced Quantification Software | LLZ | 2017-05-30 | 26 |
| K163020 | Xperius Ultrasound System | IYN | 2016-11-16 | 16 |
| K162549 | Lumify Ultrasound System | IYN | 2016-10-03 | 20 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philips Health Care.
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 Health Care (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 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)
- Philips Int'L B.V. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philips Health Care?
FDA lists 20 510(k) clearances under the applicant name “Philips Health Care” (first 2011, latest 2020), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Philips Health Care?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Health Care is 40 days. Since 2017: 43 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Philips Health Care?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7); LLZ (System, Image Processing, Radiological, 5); DQK (Computer, Diagnostic, Programmable, 2).
Next steps
- See all 20 Philips Health Care clearances with predicates and recalls
- Run predicate analysis for product code IYN, Philips Health Care'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.