(7 days)
No
The document describes standard digital radiography image processing and does not mention AI or ML.
No
This device is for diagnostic imaging (acquiring, displaying, and transmitting images), not for treating a disease or condition.
No
The device is described as a general radiography device used for image acquisition, display, and transmission. While it captures images that can be used for diagnosis, the device itself is an imaging system, not a diagnostic one. Its purpose is to produce images, not to interpret them or provide a diagnosis.
No
The device description explicitly states it is a "general purpose x-ray system" that employs "Solid State Imager(s)" and can be equipped with a "table and/or vertical wall unit" and "up to two x-ray tubes," all of which are hardware components. While it includes software for image processing and management, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this device is a general radiography system that uses x-rays to create digital images of internal body structures (head, chest, abdomen, etc.). It works by converting x-rays into electrical signals for display and processing.
- No mention of biological samples: There is no indication that this device interacts with or analyzes any biological samples from a patient.
Therefore, this device falls under the category of medical imaging devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
This system is intended for use as a general radiography device for the head, chest, abdomen, spine, neck and limbs. This system is used for image acquisition, image display, and the transmission/output of images to external devices. Excluded indications include mammography, fluoroscopy and angiography.
Product codes
90MQB/KPR, MOB
Device Description
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 a PC based device that allows for work list management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit and is configurable with up to two x-ray tubes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, chest, abdomen, spine, neck and limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K073/65
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; DRAD-3000E, RADREX-i
510(k) Summary
| Date: | October 30, 2007 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Tustin, CA 92781-2068 | |
| NOV 16 2007 | |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs |
| (714)730-5000 | |
| Establishment Registration | |
| Number: | 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: | II (per 21 CFR 892.1650) |
| Performance Standard: | 21 CFR Subchapter J, |
| Federal Diagnostic X-ray Equipment Standard | |
| Predicate Device(s): | Philips Medical Systems Bucky Vision (Digital Diagnost) |
| 510(k) Control Number: K982795 | |
| Reason For Submission | New 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, after appropriate 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 work list management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit and is configurable with up to two x-ray tubes.
Summary of Intended Uses:
This system is intended for use as a general radiography device for the head, chest, abdomen, spine, neck and limbs. This system is used for image acquisition, image display, and the transmission/output of images to external devices. Excluded indications include mammography, fluoroscopy and angiography.
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K.C. 73/165
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; DRAD-3000E, RADREX-i
Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. 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 outlined in 21 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
Therefore the RADREX-I complies with the same or equivalent standards and has the same intended use as the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is written in a clear, sans-serif font.
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 25th Street NW BUFFALO MN 55313
Re: K073165
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: November 8, 2007 Received: November 9, 2007
AUG 2 3 2013
Dear Mr. Job:
This letter corrects our substantially equivalent letter of November 16, 2007.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 commerce prior to May 28, 1976, 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 additional controls. Existing major 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 comply with all 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
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 11 you dosire spoolite darroot 101 your word Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Totallay 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
4
Indications for Use
510(k) Number (if known): K073165
DRAD-3000E; RADREX-i Device Name:
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 converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
Prescription Use
(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)
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Hogur Moly
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number