Pioway Medical Lab Equipment Co. Ltd. · 89-08 · CHINA
For Pioway Medical Lab Equipment Co. Ltd., import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Digital Ultrasound Scanner | Digital Ultrasound Scanner; product code is 90 I - - TX Transducer, Ultrasonic, Diagnostic | 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic; date published is 03/10/2014; address is Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA, verified against its source on 2026-09-30.
- Firm
- Pioway Medical Lab Equipment Co. Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA verified
- Date published
- 03/10/2014 verified
- Product code
- 90 I - - TX Transducer, Ultrasonic, Diagnostic | 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic each item verified
- Product
- Digital Ultrasound Scanner | Digital Ultrasound Scanner each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Pioway Medical Lab Equipment Co. Ltd. Date Published : 03/10/2014 Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
90 I - - TX Transducer, Ultrasonic, Diagnostic Date Published: 03/10/2014 Desc: Digital Ultrasound Scanner Notes: Class II 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic Date Published: 03/10/2014 Desc: Digital Ultrasound Scanner Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html