Philips Healthcare (Cleveland): FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Philips Healthcare (Cleveland)” (first 2011, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 270 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 308 |
| 2013 | 3 | 199 |
| 2014 | 1 | 357 |
| 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 1 | 1 |
Review panels
- Radiology (6)
Most recent Philips Healthcare (Cleveland) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133674 | PHILIPS IQON SPECTRAL CT | JAK | 2014-11-21 | 357 |
| K131773 | BRILLIANCE ICT | JAK | 2013-09-24 | 99 |
| K123599 | INGENUITY DIGITAL PET/CT | KPS | 2013-07-12 | 233 |
| K123576 | IMR SOFTWARE APPLICATION | JAK | 2013-06-07 | 199 |
| K113483 | ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION | JAK | 2012-09-26 | 308 |
| K103483 | INGENUITY TF PET/MR | OUO | 2011-11-23 | 362 |
Recalls
openFDA lists no recalls under a recalling firm named Philips Healthcare (Cleveland).
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.
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 Healthcare (Cleveland)?
FDA lists 6 510(k) clearances under the applicant name “Philips Healthcare (Cleveland)” (first 2011, latest 2014), across 3 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 Healthcare (Cleveland)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Healthcare (Cleveland) is 270 days.
Which FDA product codes appear under Philips Healthcare (Cleveland)?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 4); KPS (System, Tomography, Computed, Emission, 1); OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance, 1).
Next steps
- See all 6 Philips Healthcare (Cleveland) clearances with predicates and recalls
- Run predicate analysis for product code JAK, Philips Healthcare (Cleveland)'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.