PeekMed web (v1)
FDA 510(k) K222767 · Peek Health, S.A.
510(k) numberK222767
Submission
- Device name
- PeekMed web (v1)
- Applicant
- Peek Health, S.A.
Braga, PT - Received
- September 13, 2022
- Decision date
- December 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K252856 | PeekMed webQIH · Traditional | 12/22/2025SE |
| K252452 | PeekMed webQIH · Traditional | 11/12/2025SE |
| K251096 | PeekMed webQIH · Traditional | 07/14/2025SE |
| K250042 | PeekMed webQIH · Traditional | 03/19/2025SE |
| K240926 | PeekMed webLLZ · Traditional | 12/06/2024SE |
| K182464 | PeekMedLLZ · Traditional | 10/25/2018SE |
Questions and answers
When was PeekMed web (v1) cleared by the FDA?
PeekMed web (v1) (K222767) received a 510(k) decision of Substantially Equivalent on December 30, 2022, 108 days after the submission was received.
What is the product code of K222767?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.