Product Description
DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 2 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
■ REVISION HISTORY
NO DATE REVISED REASON REVISED CONTENT
0 2019-07-19 First issued All
1 2020-02-13 Periodic Review Added UDI-DI number in clause 1.5)
2 2020-05-15 Periodic Review
Added Medical Device Directive
93/42/EEC in applied standard
3 2020-06-08 Periodic Review
Added stereo analysis description in
clause 4 due to added stereo function.
Changed UI image of analysis setting in
clause 4 due to added stereo function.
4
5
6
7
8
9