# Sedecal., Sa.

- Location (FDA's records): Algete, ES
- FDA decisions: 26 (2002–2023): 26 510(k) clearances
- Product codes: IZL (17), KPR (6), MQB (3)
- 510(k) review time since 2016: median 54 days, against 47 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 41 (24 its own); citations of its devices by later devices: 64 (24 its own)
- Recalls linked to its devices: 66 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sedecal USA, Inc.: 5 (https://510kreport.com/company/sedecal-usa)
- Canon, Inc.: 4 (https://510kreport.com/company/canon)
- Meridian Medical Systems, LLC: 2 (https://510kreport.com/company/meridian-medical-systems)
- Canon USA, Inc.: 2 (https://510kreport.com/company/canon-usa)
- General Electric Co.: 1 (https://510kreport.com/company/general-electric)
- Philips Medical Systems North America, Inc.: 1 (https://510kreport.com/company/philips-medical-systems-north-america)
- Medicatech USA: 1 (https://510kreport.com/company/medicatech-usa)
- Oehm Und Rehbein GmbH: 1 (https://510kreport.com/company/oehm-und-rehbein)

## Firms that cite its devices most
- Medicatech USA: 3 (https://510kreport.com/company/medicatech-usa)
- Agfa Healthcare N.V.: 2 (https://510kreport.com/company/agfa-healthcare)
- Virtual Imaging, Inc.: 2 (https://510kreport.com/company/virtual-imaging)
- Vmi Tecnologias Ltda: 2 (https://510kreport.com/company/vmi-tecnologias)
- Del Medical, Inc.: 2 (https://510kreport.com/company/del-medical)
- Sedecal USA, Inc.: 1 (https://510kreport.com/company/sedecal-usa)
- Philips Medical Systems Dmc GmbH: 1 (https://510kreport.com/company/philips-medical-systems-dmc)
- Imix Adr Finland OY: 1 (https://510kreport.com/company/imix-adr-finland)

## Its most-cited devices
- K042876: Urs LP Digital, Millennium, Radpro (2004), cited by 8
- K133782: Nova FA DR System (2014), cited by 5
- K161345: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (2016), cited by 5
- K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems (2009), cited by 5
- K062335: Sedecal X Plus LP Plus (2006), cited by 5
- K090279: Sedecal, Millennium Plus (2009), cited by 4

## Recent decisions
- K232185: SM-IV (Aug 21, 2023)
- K222951: SM-V (Nov 21, 2022)
- K221803: PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (Jul 18, 2022)
- K212291: Phoenix (Sep 14, 2021)
- K203537: Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems (Feb 1, 2021)
- K202293: Radiographic System Challenge X (Oct 7, 2020)
- K192936: Soltus 500 (Nov 15, 2019)
- K192011: PhoeniX (Sep 25, 2019)

Source page: https://510kreport.com/company/sedecal