RADREX-I, SW V4.00 MODEL DRAD-3000E— 510(k) K122842
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K122842 for RADREX-I, SW V4.00 MODEL DRAD-3000E, Substantially Equivalent on 2012-10-09. Applicant: Toshiba America Medical Systems, In.C. Device class: 2.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tustin, CA, US
Recent devices under product code MQB
view allMore clearances from Toshiba America Medical Systems, In.C
view allRecalls naming K122842
K-number listed on FDA's recall record- Z-1958-2019 — Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.
- Z-2964-2018 — DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
- Z-3111-2017 — Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122842.
Data sourced from openFDA. This site is unofficial and independent of the FDA.