Atlas FDA

KXZ

7 FDA 510(k) clearances · Product code

104 daysmedian time to decision
198 days90th percentile
7clearances measured

FDA profile

Official device name
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Device class
Class III (high risk)
Regulation
21 CFR 884.2982
Medical specialty
Obstetrics/Gynecology
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RecordFirmDate
NOVATHERM (K851034)Medtech Products, Inc.1985-09-27
Q-SCAN THERMOGRAPHY SYSTEM (K843124)Qmax Medical, Inc.1984-11-29
BREAST & BODY HEALTH SYSTEM 2000 (K832731)American Thermal Instruments, Inc.1984-01-30
THERMASCAN (K813547)Bcd Products, Inc.1982-03-12
FLEXT-THERM (K781916)E-Z-Em, Inc.1979-02-02
FLEXI-THERM FILM (K770986)E-Z-Em, Inc.1977-09-12
ELC-THERMO-SYSTEM (K770678)Cutter Laboratories, Inc.1977-05-25

Track KXZ automatically

Every clearance here is in the API, with alerts when new ones post.