PacScan 300 Plus Ophthalmic Ultrasound

The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The system integrates A-Scan and Pachymeter…

Registry build 21.09.26

The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The system integrates A-Scan and Pachymeter capabilities into a single system. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The pachymeter is a biometric device that allows for measuring and mapping corneal thickness. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The pachymeter uses a higher frequency signal to measure shorter distances. The PacScan 300AP+ system includes a 6″ color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, 20 MHz Pachymeter probe, foot switch and operator manual.

44manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITX
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Ming FAI Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Xuzhou Yongkang Electronic Science Technology Co., Ltd. Xuzhou Jiangsu Contract manufacturer 13
Hony Medical Co., Ltd. Taishan Guangdong Contract manufacturer 10
Xian Friendship Medical Electronics Co., Ltd. Xi’An Shaanxi Contract manufacturer 10
Taijia Medical Electronics (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Chison Medical Technologies Co., Ltd. Wuxi Jiangsu Contract manufacturer 5
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

Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic

Record

Regulatory record for PacScan 300 Plus Ophthalmic Ultrasound
Listed by Sonomed, Inc., United States
FDA product code ITX
Device type Transducer, Ultrasonic, Diagnostic
Device class Class 2
Regulation 21 CFR 892.1570
Establishment Manufacturer
510(k) K092637
Record published 2016-08-10
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for PacScan 300 Plus Ophthalmic Ultrasound
Catalogue number Size Status
300A+ A-Scan Only In distribution
300AP+ A-Scan/Pachymeter In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
SonoScape Sonoscape Medical Corp. 302
Biopsy Starter Kit Civco Medical Instruments Co., Inc. 172
Sheathes Sheathing Technologies, Inc. 170
Needle Guide Civco Medical Instruments Co., Inc. 156
Sheathes3D Sheathing Technologies, Inc. 78
Ultrasound Probe Cover Biopsy Needle Guide Advance Medical Designs, Inc. 78
ultrasonic transducer Edan Instruments, Inc. 70
Unbranded Advance Medical Designs, Inc. 68
Reusable Biopsy Bracket Protek Medical Products, Inc. 60
Ultrasound Probe Cover Biopsy Needle Guide Kit Advance Medical Designs, Inc. 58
Biopsy Bracket Civco Medical Instruments Co., Inc. 56
Transducer Cover Civco Medical Instruments Co., Inc. 54

Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K092637 2009-09-24
K844031 1985-05-22

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer