DRAD3000E/Radrex-I
by Toshiba America Medical Systems, In.C
510(k) K082494
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082494 | Date12 Sep 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The DRAD3000E/RADREX-I is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology. It is a Class II medical device that received FDA 510(k) clearance under K082494 on September 12, 2008, and is substantially equivalent to a legally marketed predicate device.
The device is manufactured by Toshiba America Medical Systems, Inc. and is intended for use in radiology settings. It is supplied as a non-sterile, reusable system and is not indicated for MRI environments. Storage and handling should follow manufacturer guidelines, and the device operates under standard electrical and environmental conditions for diagnostic imaging equipment.
Other devices from Toshiba America Medical Systems, In.C
See all devices from Toshiba America Medical Systems, In.C →
Questions
AI-generated answers, 28 Sep 2026
What is the DRAD3000E/RADREX-I used for?
The DRAD3000E/RADREX-I is a Solid State X-Ray Imager (Flat Panel/Digital Imager) intended for use in radiology settings to capture diagnostic X-ray images, as stated in its description and FDA 510(k) clearance documentation.
Is the DRAD3000E/RADREX-I sterile or non-sterile, and is it single-use or reusable?
The device is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for multiple uses following proper cleaning and handling procedures per manufacturer guidelines.
What regulatory pathway was used for the DRAD3000E/RADREX-I, and when was it cleared?
The DRAD3000E/RADREX-I received FDA 510(k) clearance under K082494 on September 12, 2008, based on a determination of substantial equivalence to a legally marketed predicate device.