Brightview VCT Imaging System
FDA 510(k) K080927 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK080927
Submission
- Device name
- Brightview VCT Imaging System
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Milpitas, CA, US - Received
- April 2, 2008
- Decision date
- April 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code KPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261305 | Micsi-PetKPS · Traditional | Microstructure Imaging, Inc. | 09/11/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/28/2026SE |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | Siemens Medical Solutions USA, Inc. | 05/21/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/13/2026SE |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special | Spectrum Dynamics Medical, Ltd. | 01/13/2026SE |
| K253844 | AnyScan 3.0 NM Scanner FamilyKPS · Traditional | Mediso Medical Imaging Systems, Ltd. | 12/30/2025SE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional | Canon Medical Systems Corporation | 12/01/2025SE |
| K251401 | PennPET Explorer Positron Emission TomographKPS · Traditional | Trustees of the University of Pennsylvania | 11/25/2025SE |
| K252477 | Hybrid Viewer (00859873006240)KPS · Special | Hermes Medical Solutions AB | 09/09/2025SE |
More from Hermes Medical Solutions AB
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| K171850 | Philips CT Big BoreJAK · Traditional | 11/09/2017SE |
| K172406 | Ingenuity TFKPS · Traditional | 10/06/2017SE |
| K162838 | Philips iCT CT SystemJAK · Traditional | 04/07/2017SE |
| K163711 | IQon Spectral CTJAK · Traditional | 04/05/2017SE |
| K170086 | Pinnacle Radiation Therapy Planning SystemMUJ · Special | 02/09/2017SE |
| K160743 | Philips Ingenuity CTJAK · Traditional | 08/08/2016SE |
| K153444 | Philips Multislice CT System with Low Dose CT Lung CancerJAK · Traditional | 04/08/2016SE |
| K130992 | PINNACLE3 Radiation Therapy Planning SystemIYE · Traditional | 06/14/2013SE |
| K111336 | Ebw NM 2.0LLZ · Traditional | 05/24/2011SE |
| K111024 | Jetpack 2.0LLZ · Traditional | 04/21/2011SE |
Questions and answers
When was Brightview VCT Imaging System cleared by the FDA?
Brightview VCT Imaging System (K080927) received a 510(k) decision of Substantially Equivalent on April 11, 2008, 9 days after the submission was received.
What is the product code of K080927?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.