INGENUITY TF PET/MR— 510(k) K103483
Substantially EquivalentPhilips Healthcare (Cleveland)
FDA 510(k) clearance K103483 for INGENUITY TF PET/MR, Substantially Equivalent on 2011-11-23. Applicant: Philips Healthcare (Cleveland). Device class: 2.
Clearance details
- Applicant
- Philips Healthcare (Cleveland)
- Product code
- Code OUO
- 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 OUO
view allMore clearances from Philips Healthcare (Cleveland)
view allRecalls naming K103483
K-number listed on FDA's recall record- Z-2491-2015 — Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
- Z-1682-2015 — Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
- Z-1780-2015 — Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103483.
Data sourced from openFDA. This site is unofficial and independent of the FDA.