(14 days)
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
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 ofter annager(s), processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based device 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 optional auto stitching function.
The provided text is a 510(k) Pre-market Notification for the Toshiba DRAD-3000E, RADREX-i. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, a specific study designed to prove the device meets acceptance criteria, reported device performance figures, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or how ground truth was established.
The document focuses on demonstrating that the DRAD-3000E, RADREX-i is substantially equivalent to existing devices, primarily K073165 (another Toshiba DRAD-3000E, RADREX-i submission) and Philips Medical Systems Bucky Vision (Digital Diagnost) K982795. This type of submission relies on the fact that if a new device has the same intended use and similar technological characteristics to a legally marketed predicate device, it can be cleared without extensive new clinical trials demonstrating performance against specific acceptance criteria.
Therefore, it is not possible to fill in the requested table or answer the specific questions based on the provided text. The information requested, particularly regarding performance metrics, study design, and ground truth establishment, is typically found in detailed performance studies or clinical trials, which are not part of this 510(k) summary.
Summary of what CAN be extracted from the document:
- Device Name: DRAD-3000E, RADREX-i
- Intended Use: General radiography device, capable of providing digital images of the head, neck, spine, chest, abdomen, and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy, and angiography studies.
- Predicate Devices: Toshiba DRAD-3000E, RADREX-i [K073165] and Philips Medical Systems Bucky Vision (Digital Diagnost) [K982795].
- Reason for Submission: Modification to an existing device.
- Type of device: Solid State X-ray Imager (Flat Panel/Digital Imager).
- Regulatory Class: II (under 21 CFR 892.1650).
- Compliance: Designed and manufactured under Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020), and in conformance with applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28.
In conclusion, the provided 510(k) submission establishes substantial equivalence but does not include the detailed performance study information requested.
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; DRAD-3000E, RADREX-i
510(k) Summary
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| Date: | August 21, 2008 | SEP 1 2 2008 |
|---|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068 | |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs(714)730-5000 | |
| Establishment RegistrationNumber: | 2020563 | |
| Device Proprietary Name: | DRAD-3000E, RADREX-i | |
| Common Name: | Solid State X-ray Imager (Flat Panel/Digital Imager)[Fed. Reg. No. 892.1650, Pro. Code: 90MQB/KPR] | |
| Regulatory Class: | Under 21 CFR 892.1650) | |
| Performance Standard: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard | |
| Predicate Device(s): | Toshiba DRAD-3000E, RADREX-i [K073165]Philips Medical Systems Bucky Vision (Digital Diagnost)510(k) Control Number: K982795 | |
| Reason For Submission | Modification to existing device |
Description of this Device:
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 ofter annager(s), processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based device 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 optional auto stitching function.
Summary of Intended Uses:
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
510(k) Summary Statement. 1 of 2
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; DRAD-3000E, RADREX-i
Technological Characteristics:
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This device employs similar materials and processes as found in the predicate devices. The device produces ionizing radiation that is employed to generate radiographic images of the anatomy.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as Student of CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020,that apply to this device, will be met and reported via an initial report. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-28. - Medical Device Safety standards.
Substantial Equivalence:
The RADREX-I is of comparable type and substantially equivalent to:
Philips Digital Diagnost; [K982795] Toshiba DRAD-3000E, RADREX-i [K073165]
Therefore the RADREX-I complies with the same or equivalent standards and has the same intended use as the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
AUG 2 3 2013
Re: K082494
Trade/Device Name: DRAD-3000E; RADREX-i Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 28, 2008 Received: August 29, 2008
Dear Mr. Job:
This letter corrects our substantially equivalent letter of September 12, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device wforenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the energeneral of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is blassified (ove aoor regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I call the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse overses (21 cegulation (21 CFR Part 820). This letter requirences as sol forth in the quality of evice as described in your Section 510(k) premarket whitation. The FDA finding of substantial equivalence of your device to a legally marketed nonication. THO FDTI munis of cleation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice for your 2011.0 bill be of the Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5456. Thise, productions are and 207.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 Of RT Lat 000), proda Problem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tod may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: DRAD-3000E; RADREX-i
Indications for Use:
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converling x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
Prescription Use 1 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off)
Division of Reproductive, Abdominal an Radiological Devices 510(k) Number
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.