FDA.reportPublic FDA data

510(k) K253911

Device
Derma-2
Applicant
Neko Health AB
510(k) number
K253911
Product code
LHQ
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-20
Date received
2025-12-08
Regulation
884.2980
Classification name
System, Telethermographic (Adjunctive Use)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Per Sundström
Address
Svärdvägen 19 Danderyd SE 182 33 182 33

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LHQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K212965Smile-100 SystemNiramai Health Analytix Private Limited2022-03-10
K212412IRIS-XPMedicore Co., Ltd.2021-09-13
K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc.2021-01-06
K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health2019-03-25
K171928Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc.2017-12-08
K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC2017-01-09
K160573FirstSense Breast ExamFirst Sense Medical, LLC2016-06-01
K150457AlfaSight 9000 Thermographic SystemAlfa Thermodiagnostics, Inc.2015-04-10
K113259NOTOUCH BREASTSCANUe Lifesciences, Inc.2012-02-10
K101641AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301Ag Digital Technology Corp.2011-06-16
K073581ICI P AND S SERIES IR CAMERASTexas Infrared2008-07-11
K063047MEDHOT MTI 2000 THERMAL IMAGING SYSTEMMedhot Thermal Imaging, Inc.2006-10-19
K050239EMD THERMOGRAPHY SYSTEMEm Diagnostics, Inc.2006-03-16