INGENUITY TF PET/MR
FDA 510(k) clearance K103483 · decided 2011-11-23
Clearance details
- K-number
- K103483
- Device name
- INGENUITY TF PET/MR
- Applicant
- Philips Healthcare (Cleveland)
- Decision
- Substantially Equivalent
- Date received
- 2010-11-26
- Decision date
- 2011-11-23
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- OUO
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems recall (Z-2491-2015) | Philips Medical Systems (Cleveland) Inc | 2015-08-31 |
| Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograph recall (Z-1780-2015) | Philips Medical Systems (Cleveland) Inc | 2015-06-11 |
| Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 8823 recall (Z-1682-2015) | Philips Medical Systems (Cleveland) Inc | 2015-05-28 |
| Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagn recall (Z-1646-2012) | Philips Medical Systems (Cleveland) Inc | 2012-05-22 |