Hitachi
Probe Compatible with waterproof cover
37manufacturers in China registered for this device type
224catalogue numbers in this listing
2510(k) clearances naming this product 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 | Hitachi, Ltd., United States |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| 510(k) | K060059 |
| Record published | 2016-09-13 |
| Record revised | 2021-07-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical, Peracetic Acid, Hydrogen Peroxide, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 50 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 15 to 40 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2021-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASU-1010 | Withdrawn | |
| UST-579T-7.5 | Withdrawn | |
| EUP-B715 | Withdrawn | |
| UST-9127 | Withdrawn | |
| EUP-F334 | Withdrawn | |
| UST-52110S | Withdrawn | |
| UST-9136U | Withdrawn | |
| L441 | Withdrawn | |
| EUP-B512 | Withdrawn | |
| EUP-S52 | Withdrawn | |
| EUP-L74M | Withdrawn | |
| L46K1 | Withdrawn | |
| EUP-CV714 | Withdrawn | |
| UST-9145 | Withdrawn | |
| EUP-CV524 | Withdrawn | |
| CC41R | Withdrawn | |
| UST-5299 | Withdrawn | |
| UST-9101-7.5 | Withdrawn | |
| EUP-C715 | Withdrawn | |
| VC41V | Withdrawn | |
| UST-9146I | Withdrawn | |
| EUP-V73W | Withdrawn | |
| EUP-CV724 | Withdrawn | |
| UST-5298 | Withdrawn | |
| UST-536 | Withdrawn | |
| C22K | Withdrawn | |
| UST-533 | Withdrawn | |
| UST-5550 | Withdrawn | |
| UST-675P | Withdrawn | |
| EUP-OL334 | Withdrawn | |
| UST-5548 | Withdrawn | |
| UST-979-3.5 | Withdrawn | |
| UST-978-3.5 | Withdrawn | |
| L64 | Withdrawn | |
| UST-9132T | Withdrawn | |
| EUP-V53W | Withdrawn | |
| UST-990-5 | Withdrawn | |
| VC35 | Withdrawn | |
| UST-MC11-8731 | Withdrawn | |
| UST-9132T | Withdrawn | |
| UST-52124 | Withdrawn | |
| UST-5711-7.5 | Withdrawn | |
| L34 | Withdrawn | |
| EUP-CC531S | Withdrawn | |
| UST-536 | Withdrawn | |
| UST-984-5 | Withdrawn | |
| EUP-VV531 | Withdrawn | |
| R41R | Withdrawn | |
| UST-5410H | Withdrawn | |
| UST-934N-3.5 | Withdrawn | |
| UST-5550 | Withdrawn | |
| EUP-ES52E | Withdrawn | |
| UST-987-7.5 | Withdrawn | |
| VC34 | Withdrawn | |
| EUP-S80 | Withdrawn | |
| UST-5820-5 | Withdrawn | |
| Prosound 6 | Withdrawn | |
| UST-5412 | Withdrawn | |
| ARIETTA 65 | Withdrawn | |
| L44LA1 | Withdrawn | |
| MXS2ESLL | Withdrawn | |
| Aloka Arietta 850 | Withdrawn | |
| UST-5293-5 | Withdrawn | |
| UST-9123 | Withdrawn | |
| UST-568 | Withdrawn | |
| ASU-1014 | Withdrawn | |
| UST-MC11-8731 | Withdrawn | |
| UST-5294-5 | Withdrawn | |
| UST-586-5 | Withdrawn | |
| EUP-C524 | Withdrawn | |
| UST-9151 | Withdrawn | |
| UST-5551 | Withdrawn | |
| UST-9132I | Withdrawn | |
| UST-9112-5 | Withdrawn | |
| UST-9113P-3.5 | Withdrawn | |
| S12 | Withdrawn | |
| UST-678 | Withdrawn | |
| VL54 | Withdrawn | |
| ASU-1009 | Withdrawn | |
| C41V1 | Withdrawn | |
| UST-9102U-3.5 | Withdrawn | |
| UST-567 | Withdrawn | |
| EUP-S70 | Withdrawn | |
| UST-5413 | Withdrawn | |
| UST-9120 | Withdrawn | |
| UST-5419 | Withdrawn | |
| UST-9130 | Withdrawn | |
| S31 | Withdrawn | |
| UST-9135P | Withdrawn | |
| UST-52114P | Withdrawn | |
| UST-9124 | Withdrawn | |
| UST-987-7.5 | Withdrawn | |
| UST-2266-5 | Withdrawn | |
| UST-547 | Withdrawn | |
| MXS1 | Withdrawn | |
| UST-5542 | Withdrawn | |
| UST-52126 | Withdrawn | |
| UST-9126 | Withdrawn | |
| UST-995-7.5 | Withdrawn | |
| EUP-U533 | Withdrawn | |
| UST-5713T | Withdrawn | |
| CL4416R | Withdrawn | |
| UST-9104-5 | Withdrawn | |
| C42 | Withdrawn | |
| L43K | Withdrawn | |
| UST-974-5 | Withdrawn | |
| UST-677P | Withdrawn | |
| UST-5411 | Withdrawn | |
| S3ESEL | Withdrawn | |
| EUP-CC531 | Withdrawn | |
| EUP-C532 | Withdrawn | |
| C22P | Withdrawn | |
| C22I | Withdrawn | |
| UST-660-7.5 | Withdrawn | |
| UST-52119S | Withdrawn | |
| L442 | Withdrawn | |
| EUP-L73S | Withdrawn | |
| C25 | Withdrawn | |
| S3ESS | Withdrawn | |
| VC34A | Withdrawn | |
| EUP-B514 | Withdrawn | |
| UST-52108 | Withdrawn | |
| UST-52129 | Withdrawn | |
| UST-9133 | Withdrawn | |
| S31KP | Withdrawn | |
| UST-9104-5 | Withdrawn | |
| C41RP | Withdrawn | |
| UST-52109 | Withdrawn | |
| UST-9120 | Withdrawn | |
| EUP-B712 | Withdrawn | |
| EUP-O732T | Withdrawn | |
| L55 | Withdrawn | |
| UST-5268P-5 | Withdrawn | |
| UST-9137 | Withdrawn | |
| UST-579T-7.5 | Withdrawn | |
| UST-9132I | Withdrawn | |
| S211 | Withdrawn | |
| UST-5045P-3.5 | Withdrawn | |
| UST-5415 | Withdrawn | |
| L44K | Withdrawn | |
| UST-670P-5 | Withdrawn | |
| C41V | Withdrawn | |
| UST-981-5 | Withdrawn | |
| EUP-L53L | Withdrawn | |
| UST-52101 | Withdrawn | |
| UST-2265-2 | Withdrawn | |
| UST-5710-7.5 | Withdrawn | |
| UST-5543 | Withdrawn | |
| EUP-C511 | Withdrawn | |
| ARIETTA 70 | Withdrawn | |
| UST-995-7.5 | Withdrawn | |
| S3ESL | Withdrawn | |
| C251 | Withdrawn | |
| C25P | Withdrawn | |
| S121 | Withdrawn | |
| UST-9146T | Withdrawn | |
| UST-5512U-7.5 | Withdrawn | |
| EUP-L52 | Withdrawn | |
| UST-9118 | Withdrawn | |
| UST-944B-3.5 | Withdrawn | |
| UST-676P | Withdrawn | |
| UST-52128 | Withdrawn | |
| L44LA | Withdrawn | |
| UST-556T-7.5 | Withdrawn | |
| EUP-R54AW-19 | Withdrawn | |
| C41B | Withdrawn | |
| Noblus | Withdrawn | |
| EUP-R54AW-33 | Withdrawn | |
| UST-5524-7.5 | Withdrawn | |
| EUP-F531 | Withdrawn | |
| EUP-L53 | Withdrawn | |
| EUP-C514 | Withdrawn | |
| EUP-ES52M | Withdrawn | |
| UST-945B-5 | Withdrawn | |
| UST-9111-5 | Withdrawn | |
| UST-9128 | Withdrawn | |
| L44 | Withdrawn | |
| C42T | Withdrawn | |
| L53K | Withdrawn | |
| EUP-O54J | Withdrawn | |
| UST-9115-5 | Withdrawn | |
| S21 | Withdrawn | |
| UST-52127 | Withdrawn | |
| CC41R1 | Withdrawn | |
| ASU-1013 | Withdrawn | |
| Prosound Alpha 7 | Withdrawn | |
| UST-5417 | Withdrawn | |
| ARIETTA Prologue | Withdrawn | |
| EUP-S50A | Withdrawn | |
| C41L47RP | Withdrawn | |
| L46K | Withdrawn | |
| UST-5268P-5 | Withdrawn | |
| C41 | Withdrawn | |
| UST-9147 | Withdrawn | |
| UST-5536-7.5 | Withdrawn | |
| S42 | Withdrawn | |
| UST-5712 | Withdrawn | |
| UST-556I-7.5 | Withdrawn | |
| EUP-S72 | Withdrawn | |
| UST-534 | Withdrawn | |
| C35 | Withdrawn | |
| UST-5713T | Withdrawn | |
| UST-5536-7.5 | Withdrawn | |
| EUP-VV731 | Withdrawn | |
| S22 | Withdrawn | |
| UST-5534T-7.5 | Withdrawn | |
| R41RL | Withdrawn | |
| C22T | Withdrawn | |
| S3ESL1 | Withdrawn | |
| ASU-1012 | Withdrawn | |
| EUP-O53T | Withdrawn | |
| ARIETTA Prologue | Withdrawn | |
| EUP-C516 | Withdrawn | |
| EUP-L65 | Withdrawn | |
| UST-52105 | Withdrawn | |
| C42K | Withdrawn | |
| EUP-LV74 | Withdrawn | |
| UST-672-5/7.5 | Withdrawn | |
| PROSOUND F75 | Withdrawn | |
| EUP-L54MA | Withdrawn | |
| EUP-L75 | Withdrawn | |
| UST-5296 | Withdrawn | |
| UST-5418 | Withdrawn | |
| C252 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K011252 | 2001-05-30 |
| K926209 | 1994-06-03 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Fujifilm Healthcare Americas Corporation | UDI-DI | 2024-04-11 | Class II | Device Design | AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable). | 418 units |
| Fujifilm Healthcare Americas Corporation | 510(k) number | 2021-10-14 | Class II | Software design | When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricul | 48 US |
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.