Huqiu Imaging Tech
⚠️ Moderate Risk
FEI: 3005435248 • Suzhou, Jiangsu • CHINA
FEI Number
3005435248
Location
Suzhou, Jiangsu
Country
CHINAAddress
Feng Jiang Lu, Wuzhong, Suzhou, Jiangsu, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
RECORDS
The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2013 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/3/2012 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | Florida District Office (FLA-DO) | |
| 10/29/2012 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/11/2012 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | 289RECORDS | Florida District Office (FLA-DO) |
| 2/29/2012 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | Florida District Office (FLA-DO) | |
| 11/3/2011 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | Florida District Office (FLA-DO) | |
| 10/28/2009 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | Florida District Office (FLA-DO) | |
| 8/5/2009 | 90JACSYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC | Division of Southeast Imports (DSEI) | |
| 5/3/2007 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Huqiu Imaging Tech's FDA import refusal history?
Huqiu Imaging Tech (FEI: 3005435248) has 9 FDA import refusal record(s) in our database, spanning from 5/3/2007 to 10/9/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Huqiu Imaging Tech's FEI number is 3005435248.
What types of violations has Huqiu Imaging Tech received?
Huqiu Imaging Tech has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Huqiu Imaging Tech come from?
All FDA import refusal data for Huqiu Imaging Tech is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.