RCT800
FDA 510(k) clearance K260462 · decided 2026-04-09
Clearance details
- K-number
- K260462
- Device name
- RCT800
- Applicant
- Ray Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-12
- Decision date
- 2026-04-09
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- OAS
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Yongin-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dental Cone-beam Computed Tomography (mDX-15P Series) (K261748) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 |
| Dental X-ray System (K250839) | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026-06-11 |
| Dental Cone Beam Computed Tomography System (K260662) | Yofo Medical Technology Co., Ltd. | 2026-06-04 |
| medXion NEXUS (K253935) | medXion Technologies, Inc. | 2026-05-15 |
| Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (K260093) | VATECH Co., Ltd. | 2026-03-31 |
| myray ProXIma X6 (K252353) | Cefla S.C. | 2026-03-10 |
| Primevision 3D (K253959) | Dentsply Sirona | 2026-02-05 |
| RCT700 (K251798) | Ray Co., Ltd. | 2025-11-25 |
| Dental Computed Tomography X-ray System (K251842) | Fussen Technology Co., Ltd. | 2025-11-13 |
| GT300; GT300-C (K250060) | Genoray Co., Ltd. | 2025-10-08 |
| Dental CBCT X-ray System (K251642) | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 |
| Dental Cone Beam Computed Tomography System (K243337) | Yofo Medical Technology Co., Ltd. | 2025-04-17 |
Recalls involving this device
No recalls on record reference this clearance.