SM-V
FDA 510(k) clearance K222951 · decided 2022-11-21
Clearance details
- K-number
- K222951
- Device name
- SM-V
- Applicant
- Sedecal., Sa.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-27
- Decision date
- 2022-11-21
- Days to decision
- 55 days
- Clearance type
- Abbreviated
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Algete, ES
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| XLITE (K260236) | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 |
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| Airbile-100 (K250976) | Poskom Co., Ltd. | 2025-12-19 |
| Mobile X-ray unit (!M1) (K251710) | Solutions For Tomorrow AB | 2025-10-24 |
| BONX805 (K243864) | Bontech Co., Ltd. | 2025-09-12 |
| PROMO (K251443) | DRGEM Corporation | 2025-08-22 |
| HnX-P1, HnX-PB (K251223) | H&abyz Co., Ltd. | 2025-08-04 |
| REMEX Xcam6 (K250597) | Remedi, Inc. | 2025-07-31 |
| PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (K243473) | Prognosys Medical Systems Private Limited | 2025-07-29 |
Recalls involving this device
No recalls on record reference this clearance.