Inspira HD, Model: NL1000
FDA 510(k) K090811 · Neurologica Corporation
510(k) numberK090811
Submission
- Device name
- Inspira HD, Model: NL1000
- Applicant
- Neurologica Corporation
Danvers, MA, US - Received
- March 25, 2009
- Decision date
- August 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPS
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|---|---|---|---|
| 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
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| K250928 | OmniTom Elite with PCDJAK · Traditional | 09/08/2025SE |
| K233767 | OmniTom EliteJAK · Traditional | 06/10/2024SE |
| K213649 | BodyTom 64JAK · Traditional | 04/29/2022SE |
| K171183 | OmniTomJAK · Traditional | 08/18/2017SE |
| K142697 | NExCT 7JAK · Traditional | 12/23/2014SE |
| K102677 | Bodytom NL 4000JAK · Traditional | 03/24/2011SE |
| K051765 | Ceretom, Model NL3000JAK · Traditional | 07/14/2005SE |
Questions and answers
When was Inspira HD, Model: NL1000 cleared by the FDA?
Inspira HD, Model: NL1000 (K090811) received a 510(k) decision of Substantially Equivalent on August 27, 2009, 155 days after the submission was received.
What is the product code of K090811?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.