Ecat Exact HR Model 961
FDA 510(k) K920624 · Cti Pet Systems, Inc.
510(k) numberK920624
Submission
- Device name
- Ecat Exact HR Model 961
- Applicant
- Cti Pet Systems, Inc.
Knoxville, TN, US - Received
- February 11, 1992
- Decision date
- April 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
| 510(k) | Device | Decision |
|---|---|---|
| K050509 | Lso Pet/Ct Hirez Series, Models 2I, 6I, 16I, 64IKPS · Special | 03/25/2005SE |
| K042467 | Lso Pet/Ct Hirez 64KPS · Special | 10/01/2004SE |
| K040933 | Ecat HRRTKPS · Traditional | 06/07/2004SE |
| K033431 | Lso Pet/Ct Hirez and Lso Pet/Ct 16 HirezKPS · Special | 11/20/2003SE |
| K023768 | Ecat Pet/Ct; Ecat Lso Pet/Ct; Ecat Lso Pet/Ct 16KPS · Special | 11/25/2002SE |
| K023518 | Ecat Lso Pet/Ct 16KPS · Special | 11/08/2002SE |
| K021633 | Ecat Vision PET Scanner, Models 3000 & 5000KPS · Traditional | 08/14/2002SE |
| K013504 | Modification to: Ecat Lso Pet/Ct ScannerKPS · Special | 10/31/2001SE |
| K003241 | Ecat PET ScannerKPS · Traditional | 12/13/2000SE |
| K002584 | Ecat Accel PET ScannerKPS · Traditional | 11/16/2000SE |
Questions and answers
When was Ecat Exact HR Model 961 cleared by the FDA?
Ecat Exact HR Model 961 (K920624) received a 510(k) decision of Substantially Equivalent on April 27, 1992, 76 days after the submission was received.
What is the product code of K920624?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.