GE Medical Systems Information Technologies
⚠️ Moderate Risk
FEI: 1051778 • Jupiter, FL • UNITED STATES
FEI Number
1051778
Location
Jupiter, FL
Country
UNITED STATESAddress
100 Marquette Drive, , Jupiter, FL, 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).
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.
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 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 |
|---|---|---|---|
| 2/28/2005 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 1/4/2002 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | 126FAILS STD | Cincinnati District Office (CIN-DO) |
| 1/4/2002 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is GE Medical Systems Information Technologies's FDA import refusal history?
GE Medical Systems Information Technologies (FEI: 1051778) has 3 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 2/28/2005.
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 Information Technologies's FEI number is 1051778.
What types of violations has GE Medical Systems Information Technologies received?
GE Medical Systems Information Technologies has been cited for 4 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 Information Technologies come from?
All FDA import refusal data for GE Medical Systems Information Technologies 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.