Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal(Ti) Crystal
FDA 510(k) K991129 · Hitachi Medical Corp. of America
510(k) numberK991129
Submission
- Device name
- Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal(Ti) Crystal
- Applicant
- Hitachi Medical Corp. of America
Twinsburg, OH, US - Received
- April 2, 1999
- Decision date
- May 13, 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 |
| K991535 | Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasKPS · Traditional | 07/30/1999SE |
| K991318 | Convergence Nua for Hitachi Spectradigital V250DSP Gamma CamerasKPS · Traditional | 06/18/1999SE |
| 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 Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal(Ti) Crystal cleared by the FDA?
Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal(Ti) Crystal (K991129) received a 510(k) decision of Substantially Equivalent on May 13, 1999, 41 days after the submission was received.
What is the product code of K991129?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.