GE Medical Systems, SCS
⚠️ Moderate Risk
FEI: 1000284313 • Buc, Yvelines • FRANCE
FEI Number
1000284313
Location
Buc, Yvelines
Country
FRANCEAddress
283 rue de la Miniere, , Buc, Yvelines, France
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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2023 | 90KPRSYSTEM, X-RAY, STATIONARY | Division of Northern Border Imports (DNBI) | |
| 2/28/2022 | 90KXJTABLE, RADIOLOGIC | Division of Southeast Imports (DSEI) | |
| 6/16/2015 | 90IZDPROBE, UPTAKE, NUCLEAR | Division of Southeast Imports (DSEI) | |
| 5/25/2004 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Minneapolis District Office (MIN-DO) | |
| 4/15/2004 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Minneapolis District Office (MIN-DO) | |
| 4/15/2004 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Minneapolis District Office (MIN-DO) | |
| 1/30/2004 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is GE Medical Systems, SCS's FDA import refusal history?
GE Medical Systems, SCS (FEI: 1000284313) has 7 FDA import refusal record(s) in our database, spanning from 1/30/2004 to 1/19/2023.
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, SCS's FEI number is 1000284313.
What types of violations has GE Medical Systems, SCS received?
GE Medical Systems, SCS 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 GE Medical Systems, SCS come from?
All FDA import refusal data for GE Medical Systems, SCS 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.