Q. Freeze (Motion VUE2)
FDA 510(k) K113408 · Ge Medical Systems, LLC
510(k) numberK113408
Submission
- Device name
- Q. Freeze (Motion VUE2)
- Applicant
- Ge Medical Systems, LLC
Waukesha, WI, US - Received
- November 18, 2011
- Decision date
- February 24, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPS
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|---|---|---|---|
| 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 |
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| K253520 | Photonova Spectra, Photonova Spectra SelectJAK · Traditional | 03/20/2026SE |
| K253780 | SIGNA BoltLNH · Traditional | 02/06/2026SE |
| K253779 | SIGNA Sprint SelectLNH · Traditional | 02/05/2026SE |
| K252379 | AIR Recon DLLNH · Traditional | 12/23/2025SE |
| K251399 | SIGNA SprintLNH · Traditional | 09/11/2025SE |
| K250941 | Revolution VibeJAK · Traditional | 08/01/2025SE |
| K243667 | Sonic DLLNH · Traditional | 06/05/2025SE |
Questions and answers
When was Q. Freeze (Motion VUE2) cleared by the FDA?
Q. Freeze (Motion VUE2) (K113408) received a 510(k) decision of Substantially Equivalent on February 24, 2012, 98 days after the submission was received.
What is the product code of K113408?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.