Axialis
The AXIALIS Ophthalmic Ultrasound System consists of a base and probes for diagnostic imaging and biometric measurement of the eye. The filing identifies an A-scan probe for biometry and…
The AXIALIS Ophthalmic Ultrasound System consists of a base and probes for diagnostic imaging and biometric measurement of the eye. The filing identifies an A-scan probe for biometry and pachymetry.
The named measurements include eye axial length and corneal thickness, plus implanted IOL power calculation using the axial-length measurement. This explanation stays within the AXIALIS functions described in the filing and does not add a clinical outcome claim.
Listed Item
The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • 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.
Eye Measurements
The filing identifies an A-scan probe for biometry and pachymetry, including ultrasonic measurement of axial length, IOL power calculation from that measurement and measurement of corneal thickness.
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) | K213254 |
| Record published | 2022-01-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AXIALIS | 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.