Site-Rite
SR9v1.2.1 - Site~Rite 9 Ultrasound Software
44manufacturers in China registered for this device type
23catalogue numbers in this listing
1510(k) clearance
7recalls on this 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.
| 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
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K231283 |
| Record published | 2016-09-16 |
| Record revised | 2025-07-17 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -18 to 40 °C; Storage environment humidity 5 to 95 % RH |
| Packaging | Case of 10, box of 12 |
| Sizes | Length 12 to 96 in; needle gauge 18 to 21 G; length 20 to 40 mm |
| Distribution end date | 2024-01-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900013B01 | Needle Gauge 21 G | In distribution |
| 9001C0197 | Length 48 in | In distribution |
| 9000012 | Length 12 in | In distribution |
| 9770086R | In distribution | |
| 9770168 | Length 40 mm | In distribution |
| 9770001 | In distribution | |
| 9001C0212 | Length 48 in | In distribution |
| 9760034R | In distribution | |
| 9002096 | Needle Gauge 20 G | In distribution |
| 9770168R | Length 40 mm | In distribution |
| 9770169 | Length 20 mm | In distribution |
| 9002196 | Length 96 in | In distribution |
| 900023B01 | Length 12 in | In distribution |
| Version 1.2.1 | In distribution | |
| 9770086 | In distribution | |
| 9770090R | In distribution | |
| 9760034 | In distribution | |
| 9770169R | Length 20 mm | In distribution |
| 9001896 | Length 96 in | In distribution |
| 9001C0214 | Needle Gauge 20 G | In distribution |
| 9770090 | In distribution | |
| 9000096 | Length 96 in | In distribution |
| 9770001R | Withdrawn |
Same 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
| Clearance | Decision date |
|---|---|
| K042445 | 2004-10-19 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-11-03 | Not classified | Other | Conductivity gel pouches, labeled as sterile, and packaged in various kits may not be sterile. | 8,561 units | 2005-04-22 |
| 2004-11-03 | Not classified | Other | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. | 27,721 units | 2005-04-22 |
| 2004-11-03 | Not classified | Other | Conductivity gel pouches, labeled as sterile, may not be sterile. | 121 boxes | 2005-04-22 |
| 2004-11-03 | Not classified | Other | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. | 34,619 units | 2005-04-22 |
| 2004-11-03 | Not classified | Other | Conductivity gel pouches, labeled as sterile, may not be sterile. | 2360 units | 2005-04-22 |
| 2004-11-03 | Not classified | Other | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. | 121,435 units | 2005-04-22 |
| 2004-11-03 | Not classified | Other | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. | 46,141 units | 2005-04-22 |
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.