ImagePilot
FDA 510(k) K210066 · Konica Minolta, Inc.
510(k) numberK210066
Submission
- Device name
- ImagePilot
- Applicant
- Konica Minolta, Inc.
Hino-Shi, JP - Received
- January 11, 2021
- Decision date
- May 6, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K250665 | SKR 3000MQB · Traditional | 06/17/2025SE |
| K241319 | SKR 3000MQB · Traditional | 11/21/2024SE |
| K240281 | Bone Suppression SoftwareLLZ · Traditional | 05/31/2024SE |
| K230906 | Konicaminolta DI-X1LLZ · Special | 04/25/2023SE |
| K223267 | SKR 3000MQB · Special | 11/17/2022SE |
| K220993 | Ultrasound System SONIMAGE MX1IYN · Traditional | 06/23/2022SE |
| K213908 | SKR 3000MQB · Traditional | 01/31/2022SE |
| K212685 | Konicaminolta DI-X1LLZ · Special | 09/13/2021SE |
| K210619 | SKR 3000MQB · Traditional | 08/24/2021SE |
| K191645 | SKR 4000MQB · Traditional | 08/16/2019SE |
Questions and answers
When was ImagePilot cleared by the FDA?
ImagePilot (K210066) received a 510(k) decision of Substantially Equivalent on May 6, 2021, 115 days after the submission was received.
What is the product code of K210066?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.