OEC Elite
FDA 510(k) clearance K170752 · decided 2017-05-19
Clearance details
- K-number
- K170752
- Device name
- OEC Elite
- Applicant
- Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-13
- Decision date
- 2017-05-19
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Oec Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Zenition 30 (K254205) | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| Shield System (Siemens 30x40) (K260607) | Radiaction , Ltd. | 2026-07-31 |
| SmartCT (R3.0 (L10)) (K253670) | Philips Medical Systems B.V. | 2026-07-10 |
| C-beam (K252735) | Pulmera, Inc. | 2026-05-22 |
| Intelligent NR (K252503) | Canon, Inc. | 2026-04-30 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| BELLIGER ACE (K252229) | Genoray Co., Ltd. | 2026-04-02 |
| Trinias (K252099) | Shimadzu Corporation | 2026-03-24 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (K253584) | Canon Medical Systems Corporation | 2026-03-10 |
| CARA System (K252500) | Cara Medical, Ltd. | 2026-02-20 |
| ArmSure Fluoroscopic Positioning System (K251992) | Savfe Co. , Ltd. | 2026-02-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot recall (Z-1819-2025) | GE Medical Systems, LLC | 2025-06-09 |
| OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C- recall (Z-0704-2025) | GE OEC Medical Systems, Inc | 2024-12-18 |
| OEC Elite Systems with 9-inch Image Intensifier recall (Z-2278-2023) | GE OEC Medical Systems, Inc | 2023-07-31 |