This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand (fixed detector only) 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 transmission/output or images to external devices. 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 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.

AI/ML Overview

The provided document K083503 is a 510(k) Pre-market Notification for the Toshiba DRAD-3000E, RADREX-I, a general-purpose x-ray system. The document does not contain information about a study that establishes performance against specific acceptance criteria for a new or modified feature that would typically require such a study (e.g., AI performance, new diagnostic capability). Instead, it primarily focuses on demonstrating substantial equivalence to predicate devices, which implies that its performance is implicitly acceptable because it is similar to already approved devices.

Therefore, many of the requested sections regarding acceptance criteria and performance studies are not explicitly stated or applicable in this 510(k) submission, as it is largely a declaration of substantial equivalence for a direct conversion flat panel detector.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The document describes the device as being "of comparable type and substantially equivalent" to its predicate devices. This means that the acceptance criteria are implicitly that the device performs at least as well as or similarly to the predicate devices. Specific quantitative acceptance criteria or objective performance results in a table are not provided because the submission mechanism is substantial equivalence, not a de novo pathway requiring novel performance benchmarks.

The "reported device performance" in this context refers to its operational characteristics and conformity to general standards, rather than specific diagnostic accuracy metrics.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Inferred from Submission)
Intended Use	Must match or be very similar to the predicate device, for radiography of head, chest, abdomen, spine, neck, and limbs; image acquisition, display, transmission/output. Excludes mammography, fluoroscopy, angiography.	The device's stated Intended Use is for radiography of the head, chest, abdomen, spine, neck and limbs, image acquisition, image display and transmission/output or images to external devices. Excluded indications include mammography, fluoroscopy and angiography studies. This matches the predicate devices.
Technological Characteristics	Must employ similar materials and processes (e.g., solid-state imager for direct conversion of x-rays) as predicate devices.	The device employs similar materials and processes as found in the predicate devices, specifically utilizing Solid State Imagers (SSXI) to convert x-rays directly into electrical signals.
Safety and Effectiveness	Must conform to all applicable Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020), and relevant Medical Device Safety standards (e.g., IEC 60601 series).	The device is designed and manufactured under the Quality System Regulations (21 CFR § 820). All requirements of the Federal Diagnostic Equipment Standard (21 CFR § 1020) and applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28 are met.
Predicate Device Similarity	Substantially equivalent to listed predicate devices (Toshiba DRAD-3000E, RADREX-i [K082494] and Philips Medical Systems Bucky Vision (Digital Diagnost) [K982795]).	The RADREX-I is stated to be substantially equivalent to Toshiba DRAD-3000E, RADREX-i [K082494] and Philips Digital Diagnost; [K982795].

Study Details (Not applicable for this type of submission)

Since this 510(k) submission primarily establishes substantial equivalence based on technological characteristics and intended use similar to existing devices, it does not describe a performance study as would be required for a novel device or AI component that needs to demonstrate specific diagnostic accuracy or efficacy. Therefore, details regarding test sets, experts, ground truth, and effectiveness studies are not provided in this document.

Sample size used for the test set and the data provenance: Not mentioned, as no specific performance study is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This system is a general x-ray imaging system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This device is an imaging system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not applicable, as this is a hardware device submission, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

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KOR3503

FEB 1 3 2009

Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; DRAD-3000E, RADREX-i 510(k) Summary

Date:	November 21, 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, with TFP-4336Aportable detector
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):	Toshiba DRAD-3000E, RADREX-i [K082494]Philips Medical Systems Bucky Vision (Digital Diagnost)510(k) Control Number: K982795
Reason For Submission	Modification to existing device

Description of this Device:

Summary of Intended Uses:

This system is intended for use in conjunction with the ceiing-suspeneded 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

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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; DRAD-3000E, RADREX-i

system is used for image acquisition, image display and transmission/output or images to external devices. Excluded indications include mammography, fluoroscopy and angiography studies.

Technological Characteristics:

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 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] Toshiba DRAD-3000E, RADREX-i [K082494]

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 a stylized blue eagle on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The text is also in blue.

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 Reviewer and Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

AUG - 9 2013

Re: K083503

Trade/Device Name: DRAD-3000E; RADREX-I with TFP-4336A portable detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: February 2. 2009 Received: February 3, 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of February 13, 2009.

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 809), please contact the Office of In Vitro 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 Division 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):

DRAD-3000E; RADREX-i with TFP-4336A portable detector Device Nama:

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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Division of Reproductive; Abdominal and

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.