Canon Medical Systems Corporation
⚠️ Moderate Risk
FEI: 3002808382 • Otawara, Tochigi • JAPAN
FEI Number
3002808382
Location
Otawara, Tochigi
Country
JAPANAddress
1385, SHIMOISHIGAMI, , Otawara, Tochigi, Japan
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).
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.
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2025 | 90LNHSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING | Division of West Coast Imports (DWCI) | |
| 3/14/2019 | 79NRJULTRASOUND, SKIN PERMEATION | Division of Southeast Imports (DSEI) | |
| 11/13/2018 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/12/2018 | 90OUOTOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE | 476NO REGISTR | Division of Northeast Imports (DNEI) |
| 11/7/2016 | 90IZLSYSTEM, X-RAY, MOBILE | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/17/2016 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | Division of Southeast Imports (DSEI) | |
| 9/16/2013 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 9/7/2004 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Canon Medical Systems Corporation's FDA import refusal history?
Canon Medical Systems Corporation (FEI: 3002808382) has 8 FDA import refusal record(s) in our database, spanning from 9/7/2004 to 2/24/2025.
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. Canon Medical Systems Corporation's FEI number is 3002808382.
What types of violations has Canon Medical Systems Corporation received?
Canon Medical Systems Corporation 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 Canon Medical Systems Corporation come from?
All FDA import refusal data for Canon Medical Systems Corporation 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.