Ge Medical Systems China

⚠️ Moderate Risk

FEI: 3003849999 • Beijing • CHINA

FEI

FEI Number

3003849999

📍

Location

Beijing

🇨🇳

Country

CHINA

🏢

Address

6f North Tower Grand Pacific Buildingba, , Beijing, , China

Moderate Risk

FDA Import Risk Assessment

47.3

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

3/3/2006

Latest Refusal

12/29/2005

Earliest Refusal

Score Breakdown

Violation Severity

54.0×40%

Refusal Volume

52.4×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

50825×

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.

34115×

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).

11810×

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).

Refusal History

Date	Product	Violations	Division
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/3/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/2/2006	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Ge Medical Systems China's FDA import refusal history?

Ge Medical Systems China (FEI: 3003849999) has 25 FDA import refusal record(s) in our database, spanning from 12/29/2005 to 3/3/2006.

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. Ge Medical Systems China's FEI number is 3003849999.

What types of violations has Ge Medical Systems China received?

Ge Medical Systems China has been cited for 3 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 Ge Medical Systems China come from?

All FDA import refusal data for Ge Medical Systems China 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.