# K992606: Canon Laser Blood Flowmeter (CLBF) Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Canon USA, Inc.
- Decided: Jun 21, 2000 after 323 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943955 (1994). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943955: Retina Flowmeter, Heidelberg Engineering (1994) Summary page 1.

## Most influential descendants
- K062416: Retinal Functional Imager (Rfi) (2006), 3 descendants of its own
- K080180: Modification to Retinal Function Imager (Rfi) (2008), 1 descendant of its own
- K193319: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System (2020), 0 descendants of its own
- K153239: LSFG-Navi (2016), 0 descendants of its own

## Indications for use
Canon Laser Blood Flowmeter CLBF model 100 is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF model 100, and it is intended to help doctors' reading of retinal images.

Source page: https://510kreport.com/device/K992606
Methodology: https://510kreport.com/methodology