Search Results
Found 4 results
510(k) Data Aggregation
K Number
K170446Device Name
LT-300 SD Digital Video Colposcope
Manufacturer
Lutech Industries, Inc.
Date Cleared
2017-05-21
(96 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
Lutech Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LT-300 SD Digital Video Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.
Device Description
Not Found
Ask a Question
K Number
K160380Device Name
LT-300 HD
Manufacturer
Lutech Industries, Inc.
Date Cleared
2016-05-13
(93 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
Lutech Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LT-300 HD digital video colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.
Device Description
LT-300 HD digital video colposcope is a digital video colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. LT-300 HD digital video colposcope is used to diagnose abnormalities and select areas for biopsy. LT-300 HD digital video colposcope acquires and displays high-resolution still and sequentially captured images and videos.
LT-300 HD digital video colposcope offers non-patient contact, fully digital and highresolution imaging of the cervix. The field of view is illuminated by circular LED group light source; a high-resolution color CCD camera provides crisp magnified color images. The images can be viewed on a commercially available color monitor.
Ask a Question
K Number
K150691Device Name
Datalys Multi-Parameter Patient Monitor
Manufacturer
Lutech Industries, Inc.
Date Cleared
2015-05-15
(58 days)
Product Code
MWI, DOA, DPS, DXN, FLL
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Lutech Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Datalys Multi-Parameter Patient Monitor 750, 760, 780 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be the user from the monitor.
The monitor models monitor parameters such as ECG (3-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.
The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.
The monitor models are not designed for home use, and are restricted to be used on one patient at a time.
The device has not been tested for and it is not intended for pediatric use.
Device Description
Not Found
Ask a Question
K Number
K143119Device Name
LT-300 Video Colposcope
Manufacturer
Lutech Industries, Inc.
Date Cleared
2014-12-18
(49 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
Lutech Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LT-300 Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.
Device Description
Not Found
Ask a Question
Page 1 of 1