Data / Medical devices / Spain / Sedecal S.A.
Sedecal S.A.: FDA-registered device maker in ALGETE Madrid(Province), Spain, 18 510(k) clearances
Sedecal S.A. is registered with the FDA (registration 9617251) in ALGETE Madrid(Province), Spain. It lists 9 device types. The FDA files 18 510(k) clearances under its listings, the newest dated August 21, 2023. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617251
- FEI number
- 3002495042
- Address
- Pelaya, 9 Pol. Ind. Rio De Janeiro, ALGETE Madrid(Province), Spain, 28110
- Owner or operator
- SEDECAL S.A. (9039772)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 30, 1999
- Registered through
- 2026
- Brand names listed
- Aero DR TX m01, BRS, Challenge-X, Chiropro, FLEXI DT, FM Plus, MILL-WBS, MILLENNIUM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Stationary Top | IXQ | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiologic | KXJ | 2 | Manufacturer | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2023 | K232185 | SM-IV | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| November 21, 2022 | K222951 | SM-V | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| July 18, 2022 | K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| February 1, 2021 | K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | KPR | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| October 7, 2020 | K202293 | Radiographic System Challenge X | KPR | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| November 15, 2019 | K192936 | Soltus 500 | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| September 25, 2019 | K192011 | PhoeniX | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| August 2, 2019 | K191813 | MobileDiagnost wDR 2.2 | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| January 26, 2018 | K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| March 21, 2014 | K133782 | NOVA FA DR SYSTEM | MQB | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| August 2, 2012 | K121410 | DRAGON LW | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| January 26, 2011 | K103522 | SEDECAL | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| March 17, 2009 | K090322 | EASY MOVING PLUS, SM-XXHF-YY | IZL | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| March 11, 2009 | K090279 | SEDECAL, MILLENNIUM PLUS | KPR | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| February 27, 2009 | K090238 | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS | KPR | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| September 14, 2006 | K062335 | SEDECAL X PLUS LP PLUS | KPR | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| November 18, 2004 | K042876 | URS LP DIGITAL, MILLENNIUM, RADPRO | KPR | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| November 2, 2001 | K012546 | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM | KPR | Substantially Equivalent | Sedecal USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 10, 2025 | 97075 | Class II | Ongoing | Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) | Sedecal sent an to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | accessdata.fda.gov |
| January 22, 2024 | 94013 | Class II | Ongoing | Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF- | Potential interference with the anti-fall system. | accessdata.fda.gov |
| December 13, 2023 | 93614 | Class II | Ongoing | Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position. | Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. | accessdata.fda.gov |
| May 23, 2023 | 92464 | Class II | Ongoing | wDR 2.2 Mobile Digital Diagnostic X-Ray System | There is a software login in issue that may prevent the user from logging in. | accessdata.fda.gov |
| February 6, 2023 | 91656 | Class II | Ongoing | Phoenix mKDR, digital mobile diagnostic x-ray system | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. | accessdata.fda.gov |
| August 12, 2022 | 90736 | Class II | Ongoing | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500 | Due to un-commanded movement of mobile x-ray unit. | accessdata.fda.gov |
| October 14, 2021 | 93651 | Class II | Ongoing | MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 | While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion. | accessdata.fda.gov |
| July 18, 2018 | 81377 | Class II | Ongoing | Sedecal NOVA FA DR System. for diagnostic radiography. | A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties. | accessdata.fda.gov |
| January 18, 2016 | 73428 | Class II | Terminated | Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spina | This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior. | accessdata.fda.gov |
| July 13, 2015 | 71714 | Class II | Terminated | RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the | Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient. | accessdata.fda.gov |
| August 6, 2014 | 70237 | Class II | Terminated | MobileDiagnost wDR motorized portable diagnostic X-ray systems. | Reports of unexpected movement. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Stationary
- All makers of System, X-Ray, Mobile
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Table, Radiographic, Stationary Top
- All makers of Holder, Radiographic Cassette, Wall-Mounted
- All makers of Tube Mount, X-Ray, Diagnostic
Updated October 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.