Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras
FDA 510(k) K991535 · Hitachi Medical Corp. of America
510(k) numberK991535
Submission
- Device name
- Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras
- Applicant
- Hitachi Medical Corp. of America
Twinsburg, OH, US - Received
- May 3, 1999
- Decision date
- July 30, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K994026 | EUB-6000 Ultrasound Diagnostic ScannerIYN · Traditional | 03/29/2000SE |
| K991318 | Convergence Nua for Hitachi Spectradigital V250DSP Gamma CamerasKPS · Traditional | 06/18/1999SE |
| K991129 | Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal(Ti) CrystalKPS · Traditional | 05/13/1999SE |
| K981434 | EUP-OL334 LaparascopicprobeITX · Traditional | 07/27/1998SE |
| K954220 | EUB-8000IYN · Traditional | 05/07/1997SE |
| K962308 | EUB-905IYO · Traditional | 07/17/1996SE |
| K954143 | Hitachi Spectradigital Series Gamma Camera SystemsKPS · Traditional | 12/22/1995SE |
| K954129 | Spectradigital Series V250DSPKPS · Traditional | 12/22/1995SE |
| K945400 | Hitachi Dynamic 3D Imaging SYSTEM,SF-VA100IZI · Traditional | 11/20/1995SE |
| K945795 | EUB-555A+IYO · Traditional | 10/27/1995SE |
Questions and answers
When was Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras cleared by the FDA?
Convergence CDR for Hitachi Spectradigital V250DSP Gamma Cameras (K991535) received a 510(k) decision of Substantially Equivalent on July 30, 1999, 88 days after the submission was received.
What is the product code of K991535?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.