INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
FDA 510(k) clearance K003853 · decided 2001-02-13
Clearance details
- K-number
- K003853
- Device name
- INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-12
- Decision date
- 2001-02-13
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- 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 |
|---|---|---|
| Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama recall (Z-0033-2014) | Philips Medical Systems (Cleveland) Inc | 2013-10-21 |
| Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of elec recall (Z-1125-2012) | Philips Medical Systems Nederlands | 2012-02-29 |
| Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker International recall (Z-2432-2010) | Philips Medical Systems North America Co. Phillips | 2010-09-17 |
| Infinion is Nuclear Magnetic Resonance Imaging. Philips Infinion 1.5T System, Picker Inter recall (Z-2433-2010) | Philips Medical Systems North America Co. Phillips | 2010-09-17 |
| MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended recall (Z-0780-2010) | Philips Medical Systems (Cleveland) Inc | 2010-02-19 |
| Intinion 1.5 T MRI Scanner. recall (Z-0272-05) | Philips Medical Systems (Cleveland) Inc | 2004-12-02 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019) | Philips Medical Systems (Cleveland), Inc. | 1988-07-27 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018) | Philips Medical Systems (Cleveland), Inc. | 1988-06-13 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S016) | Philips Medical Systems (Cleveland), Inc. | 1988-04-28 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S014) | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |