Philips Medical Systems (Cleveland), Inc.: FDA clearances and approvals
Philips Medical Systems (Cleveland), Inc. has 190 FDA 510(k) clearances (first 1977, latest 2017), across 41 product codes in 6 review panels. Median 510(k) review time: 72 days. Since 2017 its median was 96 days, against 112 days for all cleared 510(k)s in the same product codes. openFDA lists 414 product recalls by a recalling firm named Philips Medical Systems (Cleveland), Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 65 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 138 |
| 2017 | 5 | 96 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Philips Medical Systems (Cleveland), Inc.'s cleared 510(k)s took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 57 | 57 |
| JAK | System, X-Ray, Tomography, Computed | 24 | 24 |
| KPS | System, Tomography, Computed, Emission | 20 | 20 |
| KPR | System, X-Ray, Stationary | 8 | 8 |
| HAW | Neurological Stereotaxic Instrument | 7 | 7 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 6 | 6 |
| MOS | Coil, Magnetic Resonance, Specialty | 6 | 6 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 4 | 4 |
Plus 31 more product codes.
Review panels
- Radiology (172)
- Neurology (9)
- Cardiovascular (4)
- Clinical Chemistry (1)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Philips Medical Systems (Cleveland), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171850 | Philips CT Big Bore | JAK | 2017-11-09 | 141 |
| K172406 | Ingenuity TF | KPS | 2017-10-06 | 58 |
| K162838 | Philips iCT CT System | JAK | 2017-04-07 | 178 |
| K163711 | IQon Spectral CT | JAK | 2017-04-05 | 96 |
| K170086 | Pinnacle Radiation Therapy Planning System | MUJ | 2017-02-09 | 30 |
| K160743 | Philips Ingenuity CT | JAK | 2016-08-08 | 144 |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | JAK | 2016-04-08 | 133 |
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | IYE | 2013-06-14 | 65 |
| K111336 | EBW NM 2.0 | LLZ | 2011-05-24 | 12 |
| K111024 | JETPACK 2.0 | LLZ | 2011-04-21 | 9 |
180 earlier clearances. See the full list in Caduvo.
Recalls
414 product recalls in 188 recall events; 3 initiated in the last five years. Most recent: 2025-08-05.
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 (Cleveland), 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 LNI)
Frequently asked questions
How many FDA 510(k) clearances does Philips Medical Systems (Cleveland), Inc. have?
Philips Medical Systems (Cleveland), Inc. has 190 FDA 510(k) clearances (first 1977, latest 2017), across 41 product codes in 6 review panels.
How long does FDA take to clear Philips Medical Systems (Cleveland), Inc.'s 510(k)s?
The median time from FDA receipt to decision across Philips Medical Systems (Cleveland), Inc.'s cleared 510(k)s is 72 days. Since 2017: 96 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Philips Medical Systems (Cleveland), Inc. make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 57); JAK (System, X-Ray, Tomography, Computed, 24); KPS (System, Tomography, Computed, Emission, 20).
Has Philips Medical Systems (Cleveland), Inc. had device recalls?
openFDA lists 414 product recalls in 188 recall events by a recalling firm whose name matches Philips Medical Systems (Cleveland), Inc; the most recent began 2025-08-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 190 Philips Medical Systems (Cleveland), Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Philips Medical Systems (Cleveland), 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.