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.

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.

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.

AI/ML Overview

This 510(k) premarket notification is for the DRAD-3000E, RADREX-i, a general-purpose X-ray system. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria for a new AI/algorithm. Therefore, much of the requested information regarding AI device performance, sample sizes, and ground truth establishment is not available.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for device performance in the way an AI algorithm study would. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device (Philips Medical Systems Bucky Vision - Digital Diagnost, K982795). This means the device must demonstrate comparable technological characteristics and intended use.
Reported Device Performance: The document does not report specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or image quality scores from a study) for the DRAD-3000E, RADREX-i. The focus is on its functional description and safety compliance.

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance (Summary from submission)
Substantial Equivalence to Predicate	"This device employs similar materials and processes as found in the predicate device."
Intended Use	"general radiography device for the head, chest, abdomen, spine, neck and limbs. Used for image acquisition, image display, and the transmission/output of images to external devices."
Safety & Regulatory Compliance	"Designed and manufactured under Quality System Regulations (21 CFR § 820)." "In conformance with applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28."
Excluded Indications	"mammography, fluoroscopy and angiography."

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This document describes a traditional X-ray system, not an AI algorithm requiring a test set for performance evaluation. Therefore, there is no mention of a test set sample size or data provenance in the context of an AI study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not Applicable. As this is not an AI algorithm, there is no ground truth establishment by experts for a test set described in this submission.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or adjudication method is described for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically conducted for diagnostic devices (especially AI-powered ones) to compare reader performance with and without the device's assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No. This device is a hardware X-ray system, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant and not described.

7. The Type of Ground Truth Used:

Not Applicable. For this hardware device, the concept of "ground truth" in the context of diagnostic accuracy is not directly addressed within this 510(k) summary. The submission focuses on safety, functionality, and equivalence to a predicate.

8. The Sample Size for the Training Set:

Not Applicable. As this is not an AI algorithm, there is no training set described.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. No training set ground truth establishment is described.

In summary, this 510(k) submission is for a conventional X-ray imaging system. The provided text does not contain information related to AI algorithm performance studies, acceptance criteria for such, sample sizes for training/test sets, ground truth establishment, or human reader studies. The primary goal of this submission is to demonstrate substantial equivalence to an existing predicate device based on device description, intended use, and conformance to safety standards.

Summary

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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 92781-2068NOV 16 2007
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:	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:

Summary of Intended Uses:

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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.

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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

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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

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Indications for Use

510(k) Number (if known): K073165

DRAD-3000E; RADREX-i Device Name:

Indications for Use:

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

Regulation Number and Section

§ 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.