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Asahi Roentgen Ind. Co., Ltd

✅ Low Risk

FEI: 3007834844 • Kyoto, Kyoto • JAPAN

FEI

FEI Number

3007834844

📍

Location

Kyoto, Kyoto

🇯🇵

Country

JAPAN
🏢

Address

376-3 Kuzetsukiyama-Cho, 376-3 TSUKIYAMA-CHO, KUZE, Minami; Kuzetsukiyama-Cho; Minami, Kyoto, Kyoto, Japan

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/20/2009
Latest Refusal
8/20/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

5081×

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

DateProductViolationsDivision
8/20/2009
76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Asahi Roentgen Ind. Co., Ltd's FDA import refusal history?

Asahi Roentgen Ind. Co., Ltd (FEI: 3007834844) has 1 FDA import refusal record(s) in our database, spanning from 8/20/2009 to 8/20/2009.

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. Asahi Roentgen Ind. Co., Ltd's FEI number is 3007834844.

What types of violations has Asahi Roentgen Ind. Co., Ltd received?

Asahi Roentgen Ind. Co., Ltd has been cited for 2 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 Asahi Roentgen Ind. Co., Ltd come from?

All FDA import refusal data for Asahi Roentgen Ind. Co., Ltd 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.