(42 days)
No
The document describes a standard X-ray system with image processing capabilities but does not mention AI, ML, or related concepts like DNNs, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as an X-ray system intended for taking diagnostic radiographic exposures, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures." The term "diagnostic radiographic exposures" clearly indicates its primary function is for diagnosis.
No
The device description clearly states it is a "stand-alone X-ray exposure system comprised of a U- arm... Fuji's image reader... Fuil's CR/DR Console (IIP), and Sedecal's X-ray source and U-Arm system". This indicates the device includes significant hardware components beyond just software.
Based on the provided text, the FUJIFILM Unity SpeedSuite X-Ray System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that this system is used for taking diagnostic radiographic exposures of various body parts directly on the patient (skull, spinal column, chest, abdomen, extremities, etc.).
- The system uses X-ray imaging. IVD devices typically involve laboratory tests on biological samples (blood, urine, tissue, etc.).
- The intended use is for diagnostic radiographic exposures. This refers to creating images of internal structures using X-rays, not analyzing biological samples.
Therefore, the FUJIFILM Unity SpeedSuite X-Ray System is a medical imaging device, specifically an X-ray system, and not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
KPR, MQB
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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)
The results of bench user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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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
-
- 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.
-
- 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.
-
- 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
-
- 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.
1
| Characteristic | Sedecal URS X-Ray
Units with Digital
Detector
#K042876
(Predicate Device) | FUJIFILM Unity
SpeedSuite
(Proposed Device)
(Combines three
cleared devices: Fuji
K033561/K041990
AND Sedecal
K012546) |
|--------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | General purpose
diagnostic X-ray unit | SAME |
| User Interface | Depends on Control
Console option chosen.
Mainly dedicated touch
controls | Software Driven Touch
Panel LCD, + remote
control unit + remote
console |
| 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 |
| Image Acquisition | Digital: CANON
CXDI-50G. K031447 | Digital: Fuji Computed
Radiography (FCR)
Velocity K033561 |
| Digital Panel Size | Up to 14" x 17" active
area | 17" x 17" active area |
| Digital Resolution | 160 micron pixels, with
approximately 6
million pixels | 100 micron pixels, 15
million pixels. |
| Method of Control | Dedicated push button
Controls | Software Driven Touch
Panel LCD |
| Collimator | Manual R302/A | Automatic, Huestis
150PBL |
-
- 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.
- Substantial Equivalence Chart, FUJIFILM Unity SpeedSuite
2
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.
3
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
4
Indications for Use
510(k) Number (if known): KO7365 O
Device Name: FUJIFILM Unity SpeedSuite
Indications For Use:
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.
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 _