Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4
FDA 510(k) K021656 · Nuclear Diagnostics
510(k) numberK021656
Submission
- Device name
- Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4
- Applicant
- Nuclear Diagnostics
Stockholm, SE - Received
- May 20, 2002
- Decision date
- June 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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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| K002782 | Hermes HD Aq Acquisition Station and Hermes WorkstationLLZ · Traditional | 12/05/2000SE |
| K923917 | Elipase Human Pancreatic Lipase EnzymeimmunoassayCHI · Traditional | 02/25/1994SE |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad KitJNO · Traditional | 12/02/1993SE |
| K872177 | Tipsep-Cortisol Ria Diagnostic KitCGR · Traditional | 06/17/1987SE |
| K862312 | Enzlipase, Enzymatic Lipase KitCHI · Traditional | 09/26/1986SE |
| K860472 | Nuclear Laser Alignment System for Cardic StressIWE · Traditional | 07/03/1986SE |
| K861735 | Tipsep-Tbg AssayCEE · Traditional | 06/13/1986SE |
| K852291 | Tipsep Digoxin RiaDNL · Traditional | 06/25/1985SE |
| K833713 | Serum Thyrotropin Assay Kit, Tipsep-JLW · Traditional | 12/29/1983SE |
| K823860 | Nuclipase (I125) Pancreatic LipaseCET · Traditional | 04/18/1983SE |
Questions and answers
When was Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4 cleared by the FDA?
Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4 (K021656) received a 510(k) decision of Substantially Equivalent on June 13, 2002, 24 days after the submission was received.
What is the product code of K021656?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.