BladderScan®
BladderScan® Prime Plus™ Console
37manufacturers in China registered for this device type
38catalogue numbers in this listing
5510(k) clearances naming this product code
5recalls on this code
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 | Verathon Inc., United States |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K172356 |
| Record published | 2016-09-24 |
| Record revised | 2024-11-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Case, pack of 25 |
| Distribution end date | 2025-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| i10™ | In distribution | |
| i10™ | In distribution | |
| BladderScan® Carrying Case | In distribution | |
| i10™ | In distribution | |
| i10™ | In distribution | |
| i10™ | In distribution | |
| Prime | In distribution | |
| Prime | In distribution | |
| BVI 6000 Series | In distribution | |
| Pediatric Phantom | In distribution | |
| i10™ | In distribution | |
| BVI 6000 Series | In distribution | |
| BVI 6000 Series | In distribution | |
| BVI 6000 Series | In distribution | |
| BVI 3000 | In distribution | |
| BVI 6000 Series | In distribution | |
| BVI 6000 Series | In distribution | |
| Prime | In distribution | |
| Prime | In distribution | |
| Tissue-Equivalent Phantom | In distribution | |
| BVI 6000 Series | In distribution | |
| BVI 6000 Series | In distribution | |
| BVI 3000 | Withdrawn | |
| BVI 3000 | Withdrawn | |
| BVI 9400 | Withdrawn | |
| BVI 3000 | Withdrawn | |
| BVI 3000 | Withdrawn | |
| BVI 3000 | Withdrawn | |
| Training Phantom | Withdrawn | |
| BVI 3000 | Withdrawn | |
| Prime | Withdrawn | |
| Prime Plus™ | Withdrawn | |
| BVI 3000 | Withdrawn | |
| Prime | Withdrawn | |
| BVI 3000 | Withdrawn | |
| BVI 6000 Series | Withdrawn | |
| BVI 9400 | Withdrawn | |
| BVI 9400 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hitachi | Hitachi, Ltd. | 224 |
| eTRAX™ Needle | Civco Medical Instruments Co., Inc. | 43 |
| 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 |
| System, Imaging, Pulsed Echo, Ultrasonic | GE Healthcare Austria GmbH & Co OG | 18 |
Showing 12 of 805. All products under System, Imaging, Pulsed Echo, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172356 | 2017-09-15 |
| K153101 | 2015-11-19 |
| K090214 | 2009-03-13 |
| K082456 | 2008-12-01 |
| K071217 | 2007-05-17 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Verathon Inc. | 510(k) number | 2010-09-20 | Not classified | Software design (manufacturing process) | Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect th | 70 units | 2011-04-01 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-11-30 | Class II | Device Design | The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be | 2524 units total (1441 units of BVI 9600 and 820 units of AM | 2016-10-12 |
| 2010-08-23 | Not classified | Software design | The AortaScan AMI 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function. | 73 units | 2011-09-08 |
| 2010-08-23 | Not classified | Software design | The BladderScan BVM 9500 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function. | 260 units | 2011-09-08 |
| 2010-08-23 | Not classified | Software design | The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function. | 351 units | 2011-09-08 |
| 2009-05-18 | Not classified | Software design | Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after 12/31/2009. Calibration sensitivity. | 1,978 | 2010-10-07 |
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.