TOPCON MEDICAL SYSTEMS INC

HARMONY · General and Plastic Surgery

510(k): 1 Recall: 1 UDI: 0 MAUDE: 0 Class.: 0

510(k) Clearances (1)

Harmony

2018-09-28

Substantially Equivalent

Recalls (1)

Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.

2020-12-18

Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record