Sm-Iv
FDA 510(k) K232185 · Sedecal., Sa.
510(k) numberK232185
Submission
- Device name
- Sm-Iv
- Applicant
- Sedecal., Sa.
Algete, ES - Received
- July 24, 2023
- Decision date
- August 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
| K253058 | Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 06/18/2026SE |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | DRGEM Corporation | 05/14/2026SE |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional | Poskom Co., Ltd. | 02/23/2026SE |
| K250976 | Airbile-100IZL · Traditional | Poskom Co., Ltd. | 12/19/2025SE |
| K251710 | Mobile X-ray unit (!M1)IZL · Traditional | Solutions For Tomorrow AB | 10/24/2025SE |
| K243864 | BONX805IZL · Traditional | Bontech Co., Ltd. | 09/12/2025SE |
| K251443 | PromoIZL · Traditional | DRGEM Corporation | 08/22/2025SE |
| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
More from H&abyz Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222951 | Sm-VIZL · Abbreviated | 11/21/2022SE |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.IZL · Special | 07/18/2022SE |
| K212291 | PhoenixIZL · Traditional | 09/14/2021SE |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsKPR · Abbreviated | 02/01/2021SE |
| K202293 | Radiographic System Challenge XKPR · Abbreviated | 10/07/2020SE |
| K192936 | Soltus 500IZL · Special | 11/15/2019SE |
| K192011 | PhoeniXIZL · Abbreviated | 09/25/2019SE |
| K191813 | MobileDiagnost wDR 2.2IZL · Special | 08/02/2019SE |
| K173299 | Dragon X SPSL4HC, Dragon X SPSL8HCIZL · Special | 01/26/2018SE |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRIZL · Special | 07/06/2016SE |
Questions and answers
When was Sm-Iv cleared by the FDA?
Sm-Iv (K232185) received a 510(k) decision of Substantially Equivalent on August 21, 2023, 28 days after the submission was received.
What is the product code of K232185?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.