General Electric Med Sys Opera
⚠️ Moderate Risk
FEI: 2183289 • New Berlin, WI • UNITED STATES
FEI Number
2183289
Location
New Berlin, WI
Country
UNITED STATESAddress
16800 W Ryerson Rd, , New Berlin, WI, United States
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 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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 8/25/2011 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | Los Angeles District Office (LOS-DO) | |
| 8/25/2011 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | Los Angeles District Office (LOS-DO) | |
| 1/5/2009 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | 237NO PMA | New York District Office (NYK-DO) |
| 3/22/2007 | 90LNHSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is General Electric Med Sys Opera's FDA import refusal history?
General Electric Med Sys Opera (FEI: 2183289) has 4 FDA import refusal record(s) in our database, spanning from 3/22/2007 to 8/25/2011.
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. General Electric Med Sys Opera's FEI number is 2183289.
What types of violations has General Electric Med Sys Opera received?
General Electric Med Sys Opera has been cited for 5 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 General Electric Med Sys Opera come from?
All FDA import refusal data for General Electric Med Sys Opera 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.