Toshiba Medical Systems Co Ltd
⚠️ Moderate Risk
FEI: 1000483085 • Bunkyo-Ku, Tokyo • JAPAN
FEI Number
1000483085
Location
Bunkyo-Ku, Tokyo
Country
JAPANAddress
26-5 Hongo 3-Chome, , Bunkyo-Ku, Tokyo, 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
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).
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 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 |
|---|---|---|---|
| 11/14/2011 | 90MQBSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/20/2011 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | Florida District Office (FLA-DO) | |
| 7/13/2011 | 90MQBSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Division of Southeast Imports (DSEI) | |
| 1/14/2010 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/14/2010 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/28/2008 | 76KZNSCANNER, COLOR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/16/2007 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Toshiba Medical Systems Co Ltd's FDA import refusal history?
Toshiba Medical Systems Co Ltd (FEI: 1000483085) has 7 FDA import refusal record(s) in our database, spanning from 2/16/2007 to 11/14/2011.
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. Toshiba Medical Systems Co Ltd's FEI number is 1000483085.
What types of violations has Toshiba Medical Systems Co Ltd received?
Toshiba Medical Systems Co Ltd has been cited for 3 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 Toshiba Medical Systems Co Ltd come from?
All FDA import refusal data for Toshiba Medical Systems 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.