510(k) Report

Devices descending from K973450

23 later devices reach Sensor Pad through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042250SensatouchAluna Management Co., Ltd.20041—
+1K023390MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC200221—
+1K991469Aware PadAac Consulting Group, Inc.199922—
+2K071787Bemitt, Model 0001Dja Distributors, LLC20070—
+2K070344Liv Breast Self Examination AidLiv International USA, Inc.20070—
+2K050602AltaireHitachi Medical Systems America, Inc.200517—
+3K052172HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc.2005163
+4K192650i_Space 1.5T Superconducting Magnetic Resonance Imaging SystemMri Division,Beijing Wandong Medical Technology Co., Ltd.20211—
+4K083533Echelon C Mri SystemHitachi Medical Systems America, Inc.2009112
+4K072279Magnetic Resonance Diagnostic DeviceHitachi Medical Systems America, Inc.200705
+4K061950HHF1 Echelon Multi-Purpose CoilHitachi Medical Systems America, Inc.20060—
+5K221025i_ Field 1.5T Superconducting Magnetic Resonance Imaging SystemMri Division,Beijing Wandong Medical Technology Co., Ltd.20220—
+5K113145Echelon Oval Mri SystemHitachi Medical Systems America, Inc.2012103
+6K151015ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc.201561
+6K142734TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc.20152—
+7K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.20160—
+7K160152Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.20160—
+7K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.201652
+8K172110ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation201841
+9K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation20233—
+10K233687ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation20242—
+11K241429ECHELON Synergy MRI SystemFujifilm Healthcare Corporation20241—
+12K251386ECHELON SynergyFujifilm Corporation20250—