EOS System
510(k) K152788
EOS System is a Class II device made by Eos Imaging, cleared under FDA 510(k) K152788 on 21 Oct 2015, 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 | NumberK152788 | Date21 Oct 2015 | StatusActive |
Official records
- FDA 510(k) database K152788
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152788
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 | |||
|---|---|---|---|---|
| EOS® 3.3 | 3.3 | 03663999000009 | — | On the market |
| EOS® 3.4 | 3.4 | 03663999000016 | — | On the market |
Similar devices
Other devices filed under FDA product code KPR (System, X-Ray, Stationary).
- MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM by Medicor USA, Ltd.
- UNIEXPERT 2 PLUS by Adani
- TOPOGRAPHIC IMAGING MARKER by IZI MEDICAL PRODUCTS LLC
- DigiX FDX by Allengers Medical Systems Limited
- DuraDiagnost by Philips Healthcare (Suzhou) Co., Ltd.
- MULTIX SELECT DR by Siemens Medi Cal Solutions, Inc.
- uDR 592h, uDR 596i by Shanghai United Imaging Healthcare Co., Ltd.
- GXR-Series Diagnostic X-Ray System by DRGEM Corporation
- INNOVISION-DXII by Dk Medical Systems Co., Ltd.
- JOVI MYELOGRAPHY HARNESS by Jovi, Inc.