# K090322: Easy Moving Plus, SM-XXHF-YY - Pathway: 510(k) (Special) - Applicant: Sedecal., Sa. - Decided: Mar 17, 2009 after 36 days - Product code: IZL (System, X-Ray, Mobile) - Device class: 2 - Regulation: 21 CFR 892.1720 - Recalls of this device: 31 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K981556 (1998). 8 ancestors in all. 50 later devices descend from it; 4 cite it directly. 0 of 59 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K012663: Easy Moving Mobile X-Ray Unit (Model SM-HF), Sedecal USA, Inc. (2001) Summary page 1. - K043002: Sedecal Mobile X-Ray Units with Digital Detector, Sedecal., Sa. (2004) Summary page 1. ## Most influential descendants - K142492: GM60A-32S, GM60A-40S (2014), 25 descendants of its own - K150097: GM60A-32S & GM60A-40S (2015), 24 descendants of its own - K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own - K171119: GM85 (2017), 22 descendants of its own - K173828: GU60A & GU60A-65 (2018), 19 descendants of its own ## Recalls of this device - Jun 10, 2025 · Class II · Z-0253-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0256-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0265-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0268-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0269-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0270-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0271-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0272-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0279-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0286-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0255-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0258-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0260-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0261-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0266-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0273-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0274-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0280-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0254-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0257-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0259-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0262-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0263-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0267-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0277-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0278-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0282-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0283-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0287-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0264-2026: Sedecal sent an email 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 po - Jun 10, 2025 · Class II · Z-0275-2026: Sedecal sent an email 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 po ## Indications for use These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Source page: https://510kreport.com/device/K090322 Methodology: https://510kreport.com/methodology