PRISM XPVT SYSTEM (210823)
FDA 510(k) clearance K964712 · decided 1997-02-21
Clearance details
- K-number
- K964712
- Device name
- PRISM XPVT SYSTEM (210823)
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-25
- Decision date
- 1997-02-21
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KPS
- 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 |
|---|---|---|
| AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray syst recall (Z-1775-2015) | Philips Medical Systems (Cleveland) Inc | 2015-06-11 |
| Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX recall (Z-0988-2012) | Philips Medical Systems (Cleveland) Inc | 2012-02-10 |
| Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 441 recall (Z-1510-2008) | Philips Medical Systems (Cleveland) Inc | 2008-09-19 |
| Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 441 recall (Z-1511-2008) | Philips Medical Systems (Cleveland) Inc | 2008-09-19 |
| Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Philips Medical System, Cl recall (Z-1512-8) | Philips Medical Systems (Cleveland) Inc | 2008-09-19 |
| Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. recall (Z-0093-04) | Philips Medical Systems (Cleveland) Inc | 2003-11-06 |
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 |