SubtlePET
FDA 510(k) K182336 · Subtle Medical, Inc.
510(k) numberK182336
Submission
- Device name
- SubtlePET
- Applicant
- Subtle Medical, Inc.
Menlo Park, CA, US - Received
- August 28, 2018
- Decision date
- November 30, 2018
- 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 |
|---|---|---|
| K254120 | SubtleHD-CT (1.x)QIH · Traditional | 05/15/2026SE |
| K254013 | SubtleHD-PET (1.x)LLZ · Traditional | 05/14/2026SE |
| K243250 | SubtleHD (1.x)QIH · Traditional | 02/12/2025SE |
| K240290 | AiMIFY (1.x)LLZ · Traditional | 08/21/2024SE |
| K241329 | SubtleSYNTH (1.x)QIH · Traditional | 07/11/2024SE |
| K233699 | SubtleREFORMAT (1.x)LLZ · Traditional | 04/29/2024SE |
| K223623 | SubtleMR (2.3.x)LLZ · Traditional | 05/11/2023SE |
| K211964 | SubtlePETKPS · Traditional | 09/28/2021SE |
| K203182 | SubtleMRLLZ · Traditional | 02/26/2021SE |
| K191688 | SubtleMRLLZ · Traditional | 09/16/2019SE |
Questions and answers
When was SubtlePET cleared by the FDA?
SubtlePET (K182336) received a 510(k) decision of Substantially Equivalent on November 30, 2018, 94 days after the submission was received.
What is the product code of K182336?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.