Autoalign
FDA 510(k) K021191 · Cortechs Labs, Inc.
510(k) numberK021191
Submission
- Device name
- Autoalign
- Applicant
- Cortechs Labs, Inc.
Charlestown, MA, US - Received
- April 15, 2002
- Decision date
- July 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K261916 | NeuroQuant PETLLZ · Traditional | 08/12/2026SE |
| K241098 | NeuroQuantQIH · Traditional | 08/22/2024SE |
| K210831 | OnQ NeuroQIH · Traditional | 11/19/2021SE |
| K170981 | NeuroQuantLLZ · Traditional | 09/07/2017SE |
| K061855 | NeuroquantLLZ · Traditional | 08/10/2006SE |
| K032186 | AutoalignLLZ · Abbreviated | 10/14/2003SE |
| K012563 | Deep GrayLLZ · Abbreviated | 11/02/2001SE |
Questions and answers
When was Autoalign cleared by the FDA?
Autoalign (K021191) received a 510(k) decision of Substantially Equivalent on July 12, 2002, 88 days after the submission was received.
What is the product code of K021191?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.