Medical device manufacturer
Philips Medical Systems (Cleveland), Inc.
Philips Medical Systems (Cleveland), Inc. holds 190 FDA 510(k) clearances across 39 product codes. Median elapsed review time is 71 days. openFDA lists 414 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 190
- Product codes
- 39
- Median review
- 71 days
- Recall records
- 414
How does FDA spell Philips Medical Systems (Cleveland), Inc.?
FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Philips Medical Systems (Cleveland) Inc | device/recall | normalised |
| Philips Medical Systems (Cleveland) Inc | device/enforcement | normalised |
| Philips Medical Systems (Cleveland), Inc. | device/registrationlisting | normalised |
| Philips Medical Systems (Cleveland), Inc. | device/enforcement | normalised |
| Philips Medical Systems (Cleveland), Inc. | device/recall | normalised |
| Philips Medical Systems (Cleveland), Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Philips Medical Systems (Cleveland), Inc. file in?
39 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 57 | 76 days | |
| JAK | System, X-Ray, Tomography, Computed | 24 | 88 days | |
| KPS | System, Tomography, Computed, Emission | 20 | 17 days | |
| KPR | System, X-Ray, Stationary | 8 | 38 days | |
| HAW | Neurological Stereotaxic Instrument | 7 | 90 days | |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 6 | 51 days | |
| MOS | Coil, Magnetic Resonance, Specialty | 6 | 74 days | |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 5 | 45 days | |
| LLZ | System, Image Processing, Radiological | 5 | 65 days | |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 4 | 25 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 42 days | |
| IZL | System, X-Ray, Mobile | 4 | 20 days | |
| IYX | Camera, Scintillation (Gamma) | 3 | 92 days | |
| IZH | System, X-Ray, Mammographic | 3 | 128 days | |
| DXK | Echocardiograph | 2 | 102 days | |
| IXR | Table, Radiographic, Tilting | 2 | 49 days | |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 34 days | |
| IZF | System, X-Ray, Tomographic | 2 | 18 days | |
| IZI | System, X-Ray, Angiographic | 2 | 34 days | |
| KXJ | Table, Radiologic | 2 | 34 days | |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 30 days | |
| DPS | Electrocardiograph | 1 | 21 days | |
| DSI | Detector And Alarm, Arrhythmia | 1 | 183 days | |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 52 days | |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 | 72 days |
Showing the 25 they file in most, of 39.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Philips Medical Systems (Cleveland), Inc. had a recall?
openFDA lists 414 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-2570-2025Class IIOpen, ClassifiedMUJ
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Z-2239-2025Class IIOpen, ClassifiedMUJ
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Z-1744-2022Class IIOpen, ClassifiedMUJ
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
Z-0213-2020Class ITerminatedKPS
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Z-0214-2020Class ITerminatedKPS
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Showing the 5 most recently initiated of 414.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Philips Medical Systems (Cleveland), Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K171850 | Philips CT Big Bore | JAK | 141 | |
| K172406 | Ingenuity TF | KPS | 58 | |
| K162838 | Philips iCT CT System | JAK | 178 | |
| K163711 | IQon Spectral CT | JAK | 96 | |
| K170086 | Pinnacle Radiation Therapy Planning System | MUJ | 30 | |
| K160743 | Philips Ingenuity CT | JAK | 144 | |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | JAK | 133 | |
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | IYE | 65 | |
| K111336 | EBW NM 2.0 | LLZ | 12 | |
| K111024 | JETPACK 2.0 | LLZ | 9 |
Source: openFDA device/510k · retrieved
Where is Philips Medical Systems (Cleveland), Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Philips Medical Systems (Cleveland), Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.