Vietnam MOH registration 240001561/PCBA-HCM

Medical Image Viewing and Management Software

VN: Phần mềm xem và quản lý hình ảnh y tế

Vietnam·Risk Class TBYT Loại A·HALO AP·Indica Labs Inc.·Registered Oct 14, 2024

Registration details

Analysis ID: 240001561/PCBA-HCM
Submission ID: 000.00.19.H29-241008-0024
Product Type: HALO AP

Company information

Manufacturer: Indica Labs Inc.
Manufacturer Country: UNITED STATES
Product Owner: Indica Labs Inc.
Authorized Representative: CÔNG TY TNHH ASIA ACTUAL VIETNAM

Technical details

Intended Use: For In Vitro Diagnostic Use HALO AP is a software application that is used to view and manage digital images of hematoxylin and eosin (H&E) stained surgical tissue sections that have been fixed with formalin and embedded in paraffin (FFPE). It is a tool to assist the pathologist in the interpretation of the images. The pathologist will then review and interpret the images before rendering the initial diagnostic impression. HALO AP is not intended for use with frozen tissue, cytology, or non-FFPE blood specimens. The responsibility of the pathologist is to use appropriate procedures and appropriate safeguards to ensure the accurate interpretation of the images obtained and, if necessary, to use conventional light microscopy to review and make the diagnostic decision. HALO AP is designed to be used with image scanners and display monitors that have been qualified using established test methods to meet the required performance specifications. Pathologists should use HALO AP in conjunction with their complete standard of care for the entire light microscopic image.

Dates and status

Registration Date: Oct 14, 2024

About this record

Access comprehensive regulatory information for Medical Image Viewing and Management Software in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240001561/PCBA-HCM and manufactured by Indica Labs Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ASIA ACTUAL VIETNAM.

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