HipEOS
510(k) K161479
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161479 | Date28 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K161479
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- Withdrawn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
Overview
AI-generated summary, 26 Sep 2026
The HipEOS is a Class II X-ray system used in radiology for pre-operative surgical planning for hip replacement. It features an extensive library of digital 3D models of implants from leading manufacturers, allowing for the overlay of 3D/2D implant models on radiological images and 3D reconstruction.
The HipEOS is supplied with a program that permits the selection of appropriate size and position of implants. It is a Special 510K cleared device, classified as a System, Image Processing, Radiological, with authorizations including FDA 510K. The device has been cleared by the FDA, with the most recent clearance in 2018.
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