Compact Touch
The Compact Touch is an ophthalmic ultrasound system for imaging and biometric measurement of the eye. It uses A-scan and B-scan probes to visualize internal eye and orbital structures and…
The Compact Touch is an ophthalmic ultrasound system for imaging and biometric measurement of the eye. It uses A-scan and B-scan probes to visualize internal eye and orbital structures and measure ocular dimensions.
The base unit processes and displays the ultrasound information. Measurements include eye axial length and corneal thickness, with axial length also used in intraocular lens power calculations.
Listed Item
Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
Probe Functions
The A-scan and pachymetry functions support biometry and corneal assessment, while the B-scan probe provides cross-sectional eye imaging. The described version uses a 15 MHz B-scan transducer and includes updated display connectivity.
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (9), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Showing 12 of 37. All 37 manufacturers in China registered for System, Imaging, Pulsed Echo, Ultrasonic
Record
| Listed by | Quantel Medical, France |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K180265 |
| Record published | 2018-04-13 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| COMPACT TOUCH 2017 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hitachi | Hitachi, Ltd. | 224 |
| eTRAX™ Needle | Civco Medical Instruments Co., Inc. | 43 |
| BladderScan® | Verathon Inc. | 38 |
| Verza Guidance System | Civco Medical Instruments Co., Inc. | 37 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 34 |
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 34 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 33 |
| Tracking Bracket Starter Kit | Civco Medical Instruments Co., Inc. | 29 |
| System, Imaging, Pulsed Echo, Ultrasonic | GE Healthcare Japan Corporation | 23 |
| eTRAX™ Needle System Starter Kit | Civco Medical Instruments Co., Inc. | 20 |
| Tracking Bracket | Civco Medical Instruments Co., Inc. | 19 |
| Logiq | GE Ultrasound Korea, Ltd. | 18 |
Showing 12 of 805. All products under System, Imaging, Pulsed Echo, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232302 | 2024-04-26 |
| K213254 | 2021-11-15 |
| K183414 | 2019-03-20 |
| K180265 | 2018-03-02 |
| K051851 | 2005-08-03 |
| K021683 | 2002-06-21 |
| K993674 | 2000-07-13 |
| K000554 | 2000-03-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.