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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

✅ Low Risk

FEI: 3004571294 • Tirat Carmel • ISRAEL

FEI

FEI Number

3004571294

📍

Location

Tirat Carmel

🇮🇱

Country

ISRAEL
🏢

Address

4, Hayozma St, , Tirat Carmel, , Israel

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
6/16/2015
Latest Refusal
6/16/2015
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

3411×

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).

Refusal History

DateProductViolationsDivision
6/16/2015
90NRZABLATION SYSTEM, HIGH INTENSITY FOCUSED ULTRASOUND (HIFU), MR-GUIDED
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING's FDA import refusal history?

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING (FEI: 3004571294) has 1 FDA import refusal record(s) in our database, spanning from 6/16/2015 to 6/16/2015.

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 ISRAEL, FUNCTIONAL IMAGING's FEI number is 3004571294.

What types of violations has GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING received?

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has been cited for 1 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 ISRAEL, FUNCTIONAL IMAGING come from?

All FDA import refusal data for GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 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.