510(k) Report

Devices descending from K971868

59 later devices reach Impact (Informing Mobile Personnel and Care Tracking) Pager System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994430Impact.WF Mobile Waveform Receiving SystemGeneral Electric Medical Systems Information Techn20000—
+1K992749Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc.200056—
+1K973527Cardio-Pager SystemData Critical Corp.199857—
+2K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+2K062278Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc.200621—
+3K103634Ascom Clinicalconnex CardiomaxAscom (Us), Inc.201114—
+3K102974Intellisphere Event Managment System Rel. 10.00Philips Medical Systems20115—
+3K090094Zeltiq SystemZeltiq Aesthetics200932—
+4K180430Digistat Smart CentralAscom Ums Srl Unipersonale20181—
+4K180566Unite Connect for Clinical SystemsAscom Sweden AB20182—
+4K142935CareEventPhilips Medical Systems20151—
+4K130707Isirona MagellanIsirona, LLC20130—
+4K130339Clinical Alert NotificationExtension, Inc.20135—
+4K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+4K112650Connexall Suite of Software ProductsConnexall USA, Inc.20120—
+4K112047Amcom Commtech MessengerAmcom Software,Inc.20110—
+4K111215Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB201131
+5K261287Digistat CareAscom Ums Srl Unipersonale20260—
+5K193421Smart Alarm InterfaceBoxview, LLC20202—
+5K193043Critical Alert CommonPath EnterpriseCritical Alert20201—
+5K161164CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems201603
+5K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+5K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+5K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+5K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+6K243270TigerConnect Alarm ManagementTigerconnect20250—
+6K212622Zyter RPMZyter, Inc.20220—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+6K160470SculpSureCynosure, Inc.201620—
+6K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+6K150724SculpSureCynosure, Inc.201521—
+6K150230SculpSureCynosure, Inc.201521—
+7K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+7K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+7K211681EONDominion Aesthetic Technologies, Inc.20221—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K171111SculpsureCynosure, Inc.201710—
+7K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K192970SlimusHironic Co., Ltd.20200—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K171992SculpSureCynosure, Inc.20178—
+8K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K231971Deka Physiq 360El.En S.P.A.20230—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K182741SculpSureCynosure20195—
+9K172144CoolSculpting SystemZeltiq Aesthetics20177—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+10K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805