# K012727: Humphrey OCT3

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Ophthalmic Systems, Inc.
- Decided: Jan 31, 2002 after 169 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
92 later devices descend from it; 4 cite it directly.
0 of 93 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) Humphrey Optical Coherence Tomographer: named in the summary without a submission number
- (no number) Heidelberg Retinal Tomograph: named in the summary without a submission number
- (no number) GDx by Laser Diagnostic Technologies: named in the summary without a submission number

## Most influential descendants
- K030433: Stratusoct with RNFL Normative Database (2003), 89 descendants of its own
- K033123: Stratusoct with RNFL & Macula Normative Database (2004), 77 descendants of its own
- K063343: Bioptigen Spectral Domain Ophthalmic Imaging System (2006), 70 descendants of its own
- K062552: RTVUE (2006), 65 descendants of its own
- K071250: CA, Model: Cam (2007), 64 descendants of its own

## Indications for use
The Humphrey OCT3 is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer and optic disk. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema, central serous retinopathy and glaucoma.

Source page: https://510kreport.com/device/K012727
Methodology: https://510kreport.com/methodology