Ingenuity TF— 510(k) K172406
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K172406 for Ingenuity TF, Substantially Equivalent on 2017-10-06. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code KPS
view allMore clearances from Philips Medical Systems (Cleveland), Inc.
view allRecalls naming K172406
K-number listed on FDA's recall record- Z-2193-2019 — Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
- Z-0823-2019 — Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).
- Z-0562-2018 — Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172406.
Data sourced from openFDA. This site is unofficial and independent of the FDA.