FUJIFILM Unity SpeedSuite X-Ray System is Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Description

The FUJIFILM DR Unity SpeedSuite is a stand-alone X-ray exposure system comprised of a U- arm (manufactured by Sedecal) that incorporates the following: Fuji's image reader equipped with HD Linescan technology, Fuil's CR/DR Console (IIP), and Sedecal's X-ray source and U-Arm system (Verso). Since both are paired, the height and angle can be flexibly changed while maintaining their positional relationship. This system enables you to make an exposure not only at supine or upright position but also at any other desired positions. Images taken by the Unity system are sent to Fuii's IIP (CR/DR Console) to be processed. There is an automatic collimator made by Huestis attached to the tube head. The x-ray tube is manufactured by Toshiba

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, the "acceptance criteria" for the FUJIFILM Unity SpeedSuite are primarily based on demonstrating substantial equivalence to a predicate device, the Sedecal URS LP X-Ray Units with Digital Detector (K042876). The "performance" is implicitly compared through a feature-by-feature assessment rather than explicit quantitative metrics of diagnostic accuracy.

Characteristic	Acceptance Criteria (Predicate Device K042876)	Reported Device Performance (FUJIFILM Unity SpeedSuite)
Intended Use	General purpose diagnostic X-ray unit for skull, spinal column, chest, abdomen, extremities, and other body parts.	SAME - General purpose diagnostic X-ray unit for skull, spinal column, chest, abdomen, extremities, and other body parts; for adult and pediatric subjects; patient sitting, standing, or lying.
User Interface	Depends on Control Console option chosen. Mainly dedicated touch controls.	Software Driven Touch Panel LCD, + remote control unit + remote console. (Technological difference, but deemed equivalent in function)
Maximum Output	Depends on model of generator chosen. Models available from 30 kW to 64 kW.	Depends on model of generator chosen. Models available from Sedecal range from 30kW to 80 kW. (Technological difference, broader range, deemed equivalent)
Image Acquisition	Digital: CANON CXDI-50G. K031447.	Digital: Fuji Computed Radiography (FCR) Velocity K033561. (Technological difference in detector, but deemed equivalent)
Digital Panel Size	Up to 14" x 17" active area.	17" x 17" active area. (Technological difference, larger size, deemed equivalent)
Digital Resolution	160 micron pixels, with approximately 6 million pixels.	100 micron pixels, 15 million pixels. (Technological difference, higher resolution, deemed equivalent or superior)
Method of Control	Dedicated push button Controls.	Software Driven Touch Panel LCD. (Technological difference, but deemed equivalent in function)
Collimator	Manual R302/A.	Automatic, Huestis 150PBL. (Technological difference, automation, deemed equivalent or superior)

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

The provided documentation does not mention a clinical test set with human patients or images for performance evaluation. The study focuses on demonstrating substantial equivalence through a comparison of technical specifications and the fact that the proposed device combines three already cleared devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical evaluation with expert ground truth establishment is described in these documents. The "ground truth" for this 510(k) submission is the technical specifications and cleared status of the predicate and component devices.

4. Adjudication Method

Not applicable. No clinical evaluation or expert review process requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in these documents. The submission focuses on substantial equivalence based on technical specifications and the combination of previously cleared components, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not conducted or reported. The device is a hardware system for X-ray acquisition and processing, not an AI algorithm for image interpretation.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is regulatory clearance and established performance of predicate and component devices, along with technical specifications and bench/standards testing results of the proposed device itself. There is no mention of pathology, expert consensus on patient images, or outcomes data.

8. Sample Size for the Training Set

Not applicable. This device is a diagnostic X-ray system, not an AI image analysis algorithm that requires a training set of images.

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

Not applicable. As above, there is no AI algorithm requiring a training set for this device.

Summary

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K073650

Page 15 of 910

EXHIBIT 2 510(k) Summary

419 West Avenue

Stamford, CT 06902 Phone 203/324-2000 Fax 203/353-0926

FEB - 6 2008

Contact: Debbie Peacock, Regulatory Coordinator Date Prepared: December 11, 2007

1. Identification of the Device: Proprietary-Trade Name: FUJIFILM Unity SpeedSuite Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit with digital imaging receptor.
1. Equivalent legally marketed devices: This notification is for a MODIFIED device. This device COMBINES three 510(k) cleared devices, the SEDECAL Universal Radiographic Systems K012546, the detector used in the Fujifilm Fuji Computed Radiography (FCR) Velocity Image Reader K033561, and the Fuji Medical CR/DR Console, Flash IIP. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K042876.
1. Indications for Use (intended use): Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Description of the Device: The FUJIFILM DR Unity SpeedSuite is a stand-alone X-ray 4. exposure system comprised of a U- arm (manufactured by Sedecal) that incorporates the following:
- Fuji's image reader equipped with HD Linescan technology .
- . Fuil's CR/DR Console (IIP), and
- Sedecal's X-ray source and U-Arm system (Verso).

Since both are paired, the height and angle can be flexibly changed while maintaining their positional relationship. This system enables you to make an exposure not only at supine or upright position but also at any other desired positions. Images taken by the Unity system are sent to Fuii's IIP (CR/DR Console) to be processed. There is an automatic collimator made by Huestis attached to the tube head. The x-ray tube is manufactured by Toshiba

1. Safety and Effectiveness, comparison to predicate device. The results of bench user, and standards testing indicates that the new device is as safe and effective as the predicate devices.

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Characteristic	Sedecal URS X-RayUnits with DigitalDetector#K042876(Predicate Device)	FUJIFILM UnitySpeedSuite(Proposed Device)(Combines threecleared devices: FujiK033561/K041990AND SedecalK012546)
Intended Use:	General purposediagnostic X-ray unit	SAME
User Interface	Depends on ControlConsole option chosen.Mainly dedicated touchcontrols	Software Driven TouchPanel LCD, + remotecontrol unit + remoteconsole
Maximum output	Depends on model ofgenerator chosen.Models available from30 kW to 64 kW	Depends on model ofgenerator chosen.Models available fromSedecal range from30kW to 80 kW
Image Acquisition	Digital: CANONCXDI-50G. K031447	Digital: Fuji ComputedRadiography (FCR)Velocity K033561
Digital Panel Size	Up to 14" x 17" activearea	17" x 17" active area
Digital Resolution	160 micron pixels, withapproximately 6million pixels	100 micron pixels, 15million pixels.
Method of Control	Dedicated push buttonControls	Software Driven TouchPanel LCD
Collimator	Manual R302/A	Automatic, Huestis150PBL

1. Substantial Equivalence Chart, FUJIFILM Unity SpeedSuite
  Conclusion After analyzing bench and standards testing data, it is the conclusion of FUJIFILM 7. Medical Systems, USA that the FUJIFILM Unity SpeedSuite x-ray System is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB = 6 2008

FujiFilm Medical Systems USA, Inc. % Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K073650

Trade/Device Name: FujiFilm Unity SpeedSuite (CR-IR-371) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: December 19, 2007 Received: December 26, 2007

Dear Mr. Kamm:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): KO7365 O

Device Name: FUJIFILM Unity SpeedSuite

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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 1

Vancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abo 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.