Phoenix
FDA 510(k) K212291 · Sedecal., Sa.
510(k) numberK212291
Submission
- Device name
- Phoenix
- Applicant
- Sedecal., Sa.
Algete, ES - Received
- July 22, 2021
- Decision date
- September 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
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| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
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| 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 |
|---|---|---|
| K232185 | Sm-IvIZL · Special | 08/21/2023SE |
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| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.IZL · Special | 07/18/2022SE |
| 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 Phoenix cleared by the FDA?
Phoenix (K212291) received a 510(k) decision of Substantially Equivalent on September 14, 2021, 54 days after the submission was received.
What is the product code of K212291?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.