# K961171: Humphrey Oct Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss, Inc.
- Decided: Jun 21, 1996 after 88 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
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OCT predicate device: named in the summary without a submission number

## Most influential descendants
- K993357: Iolmaster (2000), 17 descendants of its own
- K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter (2003), 16 descendants of its own
- K082891: Lenstar, Model LS900 (2009), 14 descendants of its own
- K101182: Iolmaster 500 (2010), 10 descendants of its own
- K122418: Iolmaster 500 (2013), 9 descendants of its own

## Indications for use
This device will be used in the same manner as all OCT scanner devices are used for two dimensional cross-sectional imaging of the posterior segment of the eye. It incorporates the original intended uses of our earlier claimed substantially equivalent products. It is used primarily for diagnosing and monitoring retinal diseases and disorders that manifest themselves in the posterior pole of the eye. Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.

Source page: https://510kreport.com/device/K961171
Methodology: https://510kreport.com/methodology