(85 days)
Not Found
No
The description focuses on integrating existing components and software for image acquisition and processing, with no mention of AI or ML capabilities.
No.
The device is an x-ray system used for diagnostic imaging, not for treatment.
Yes
The device's intended use explicitly states "the identification, capture, digitization, and processing of diagnostic x-ray images." This directly indicates its role in supporting diagnosis.
No
The device description explicitly lists multiple hardware components, including image readers, workstations, ID terminals, X-ray tubes, generators, collimators, tube stands, and bucky tables. While it mentions the addition of "X-CON software," it also states that X-CON refers to a "combination of software and hardware." The device is presented as a system integrating various hardware components with 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 such as blood, urine, or tissue taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that this device is a radiographic system used for capturing X-ray images of the human body. It involves X-ray generation, image capture, digitization, and processing.
- No Biological Samples: There is no mention of the device interacting with or analyzing biological samples.
Therefore, the FUJI SPBBD SUITE, as described, falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The indications for use for the FUJI SPBBD SUITE is the same as the predicate de-Inc : Indiagraphic exposures of the entire body specifically the skull, spinal column, chest, and abdomen, as well as extremities, the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.
Product codes (comma separated list FDA assigned to the subject device)
MQB, KPR
Device Description
The Speed Suite combines the following components and devices in one package.
-
Fuji Computed Radiography Image Reader (FCR 5501D, FCR 5501D-ES, or FCR 5502D table).
-
IIP Workstation
-
- ID-T741A ID terminal
- Siemens X-ray Tube (Optitop 150/40/80HC)
-
- Siemens X-ray Generator (Polydoros IT 55)
-
- Siemens Automatic Collimator (AL01)
-
- Siemens Tube Stand
- a. Floor Mounted Tube Stand Multix-L
- b. Ceiling Mounted Tube Stand 3D Top-ACSS with optional tracking
- 19} Central electronic unit (ZE)
-
- Siemens Multix Compact K bucky table
-
- Siemens Rasterwanderat bucky wall stand
-
- X-CON software
The Speed Suite utilizes devices that have already received 510(k) marketing clearance from FDA. The primary difference is the addition of the X-CON software that allows the Fuji image readers to I he primary and interface with the Siemens X-ray equipment. X-CON refers to a combination of software and hardware that will integrate the Fuji ID-T741 or IIP workstation with the Siemens Polydoros IT 55. The ID-T741 or IIP workstation will interface directly to both the Fuji image reader and to the Polydoros IT55 via cabling. The software for the ID-T741 and IIP workstation is adapted to inte wate existing patient anatomical menus according to defaults, so that a selected patient exam will display parameters for an associated x-ray exposure menus can be adjusted according to user preferences, and all defaults can be overridden. Once the patient exam is selected, the exposure data information is transferred to the generator, thus initiating the exposure according to direcsure and morniance to the fixed data for kV, mAs and spot size will be sent back to the ID-T741 terminal or IIIP workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
entire body specifically the skull, spinal column, chest, and abdomen, as well as extremities
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)
Based on validation studies and risk analysis, we believe this is a minor change that is of minimal risk.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K971452, K001201, K993861, K972256, K993861
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
DEC 2 0 2001
KOB218
510(k) Summary [as required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(1)}
September 19, 2001
Submitter's Information [21 CFR 807.92(a)(1)]
Fujifilm Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902 Telephone: (203) 602-3677 Facsimile: (203) 327-6485 Contact: Joseph M. Azary
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are:
- . Fuji Speed Suite
- Fuji Speed Suite Phase II .
The device common or classification names are: Stationary x-ray system
Predicate Device [21 CFR 807.92(a)(3)]
| Fuji identifies the predicate devices as follows: | |
|---|---|
| Siemens Multix TOP/PRO Radiographic Table | K971452 |
| Siemens Multix Compact K bucky table | K001201 |
| Fuji FCR 5501D | K993861 |
| Fuji HI-C654 Multimodality Workstation | K972256 |
| Fuji ID-T741 ID terminal | K993861 |
Description of the Device [21 CFR 807.92(a)(4)]
Summary of the function of the device and its major components:
The Speed Suite combines the following components and devices in one package.
- Fuji Computed Radiography Image Reader (FCR 5501D, FCR 5501D-ES, or FCR 5502D table).
1
- IIP Workstation
-
- ID-T741A ID terminal
- Siemens X-ray Tube (Optitop 150/40/80HC)
-
- Siemens X-ray Generator (Polydoros IT 55)
-
- Siemens Automatic Collimator (AL01)
-
- Siemens Tube Stand
- a. Floor Mounted Tube Stand Multix-L
- b. Ceiling Mounted Tube Stand 3D Top-ACSS with optional tracking
- 19} Central electronic unit (ZE)
-
- Siemens Multix Compact K bucky table
-
- Siemens Rasterwanderat bucky wall stand
-
- X-CON software
The Speed Suite utilizes devices that have already received 510(k) marketing clearance from FDA. The primary difference is the addition of the X-CON software that allows the Fuji image readers to I he primary and interface with the Siemens X-ray equipment. X-CON refers to a combination of software and hardware that will integrate the Fuji ID-T741 or IIP workstation with the Siemens Polydoros IT 55. The ID-T741 or IIP workstation will interface directly to both the Fuji image reader and to the Polydoros IT55 via cabling. The software for the ID-T741 and IIP workstation is adapted to inte wate existing patient anatomical menus according to defaults, so that a selected patient exam will display parameters for an associated x-ray exposure menus can be adjusted according to user preferences, and all defaults can be overridden. Once the patient exam is selected, the exposure data information is transferred to the generator, thus initiating the exposure according to direcsure and morniance to the fixed data for kV, mAs and spot size will be sent back to the ID-T741 terminal or IIIP workstation.
Intended Use [21 CFR 807.92(a)(5)]
The indications for use for the FUJI SPBBD SUITE is the same as the predicate de-Inc : Indiagraphic exposures of the entire body specifically the skull, spinal column, chest, and abdomen, as well as extremities, the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.
Technological Characteristics [21 CFR 807.92(a)(6)]
The subject device represents a minor revision to devices that have been already cleared by FDA. The Speed Syste groups Siemens and Fuji devices into one package and includes X-CON software which allows the Fuji Radiographic equipment to communicate with the Siemens X-ray equipment.
Performance Data [21 CFR 807.92(b)(1)]
Based on validation studies and risk analysis, we believe this is a minor change that is of minimal risk.
2
Conclusion [21 CFR 807.92(b)(3)}
Hospitals usually purchase radiographic image equipment separately from different manufacturers. The equipment is usually connected in form or another. Therefore, the Speed Suite does not introduce a new concept or technology.
In conclusion, the subject device is utilizing components that have already been cleared by FDA and have been used safely and effectively in clinical environments. The subject device includes a minor revision to the product involving software that interfaces between Fuji radiographic equipment and Siemens X-ray equipment. At anytime the exposure data can be overridden by the operator/technologist and a manual generator technique can be selected.
The components of the subject device comply with recognized safety and consensus standards.
We conclude the subject device to be as safe and effective as the predicate devices.
3
Image /page/3/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 depiction 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
Mr. Joseph M. Azary Regulatory Affairs Consultant Fujifilm Medical Systems USA, Inc. 419 West Ave. STAMFORD CT 06902
AUG 2 3 2013
Re: K013218
Trade/Device Name: Fuji Speed Suite™ and Fuji Speed Suite™ Phase II Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and KPR Dated: September 19. 2001 Received: September 26, 2001
Dear Mr. Azary:
This letter corrects our substantially equivalent letter of December 20, 2001.
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
4
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
5
5 10(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Fuji SPEED SUITE
Indications For Use:
The indications for use for the FUJI SPEED SUITE is the same as the predicate device : radiographic exposures of the entire body specifically the skull, spinal column, chest, and abdomen, as well as extremities, the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| ------------------------------------------------------- | -- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | 2013318 |
J.M Azary b:j510(k)jA5501D-510k