spineEOS
by Eos Imaging
510(k) K232086
spineEOS is a Class II device made by Eos Imaging, cleared under FDA 510(k) K232086 on 24 Oct 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232086 | Date24 Oct 2023 | StatusActive |
Official records
- FDA 510(k) database K232086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232086
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| spineEOS 3.0 | 3.0 | 03663999000184 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- Brain Perfusion (BP) application by Philips Medical Systems Nederland B.V.
- OrthoVision by Ewoosoft Co., Ltd.
- MedDream by Softneta Uab
- WELCH ALLYN FRONT-LINE DOC by Welch Allyn, Inc.
- CARESTREAM PACS by CARESTREAM HEALTH, INC.
- VitreaView by Vital Images, Inc.
- ECHOLINK by Mpacs, LLC
- CLARISO PACS by Clariso, Inc.
- AmCAD-UV by AMCAD BIOMED CORPORATION
- DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) by Howtek, Inc.