# K021683: Cinescan S

- Pathway: 510(k) (Special)
- Applicant: Quantel Medical
- Decided: Jun 21, 2002 after 30 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
Longest line of descent: 1 generation back to K926251 (1993). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926251: B-Scan Opthalmic Ultrasound Imaging System, Biovision, Inc. (1993). Our reading of the summary gave K926521, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “B-SCAN”.
- K000554: Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for Pocket, Quantel Medical (2000) Summary page 1.

## Most influential descendants
- K051851: Aviso Ophthalmic Ultrasound System (2005), 6 descendants of its own
- K094038: Compact Touch (2010), 3 descendants of its own
- K180265: COMPACT TOUCH Ophthalmic Ultrasound System (2018), 1 descendant of its own
- K213254: Axialis Ophthalmic Ultrasound System (2021), 0 descendants of its own
- K183414: Absolu (2019), 0 descendants of its own

## Indications for use
The intended use of the Cinescan S is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye. The intended use of the Cinescan S 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans.. The Quantel Medical Cinescan * Mhz A-scan transducer is intended to be used with the Quantel Cinescan S A-scans of the eye and for biometric measurements. The intended use of the Cinescan S is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.

Source page: https://510kreport.com/device/K021683
Methodology: https://510kreport.com/methodology