(17 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the description focuses on standard X-ray imaging principles.
No
The device is described as a diagnostic imaging system, not one that provides therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is indicated for use in "diagnostic and angiographic procedures". Additionally, the "Device Description" mentions that "image information is obtained for medical diagnosis treatment."
No
The device description clearly states it is a "digital radiography/fluoroscopy system" and describes the use of X-rays passing through the patient's body to obtain image information. This indicates the device includes hardware components for generating and detecting X-rays, which are not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- This device is an X-ray system used in vivo (within the body) to create images of blood vessels for diagnostic and angiographic procedures. It uses X-rays passing through the patient's body, not analyzing samples taken from the body.
The description clearly states its function is to perform fluoroscopy/radiography of the interventional angiography system using X-rays that have passed through the patient's body. This is a form of medical imaging performed directly on the patient, not an in vitro test.
N/A
Intended Use / Indications for Use
This system is a diagnostic X-ray system designed for multidirectional observation of the flow of the contrast medium injected into the blood vessels of the patient. This system is intended for use in diagnostic and interventional procedures involving the cardiac blood vessels, abdominal blood vessels, and lower limb blood vessels.
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Product codes (comma separated list FDA assigned to the subject device)
JAA, IZI
Device Description
The main function of this system is to perform fluoroscopy /radiography of the interventional angiography system. Using the fluorescent scintillation effect of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
cardiac blood vessels, abdominal blood vessels, lower limb blood vessels, heart, brain, abdomen, lower 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)
Not Found
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.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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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Toshiba America Medical Systems. Pre-Market Notification 510(k) INFX-8000V with 56 inch Monitor
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
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- SUBMITTER'S NAME Toshiba America Medical Systems, Inc.
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- ADDRESS 2441 Michelle Drive Tustin, CA. 92780-2068
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- CONTACT PERSON Paul Biggins Director, Regulatory Affairs (714) 730-5000
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- TRADE NAME(S): INFX-8000V with 56 inch Monitor
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- COMMON NAME: Solid State X-Ray Imager (Flat Panel/Digital Imager)
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- DEVICE CLASSIFICATION: Class II (per 21 FR 892.1650)
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- PRODUCT CODE / DESCRIPTION: MQB - Image-Intensified Fluoroscopic X-ray System
8. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
9. DEVICE DESCRIPTION:
The main function of this system is to perform fluoroscopy /radiography of the interventional angiography system. Using the fluorescent scintillation effect of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis treatment.
10. SUMMARY OF INTENDED USES:
This system is a diagnostic X-ray system designed for multidirectional observation of the . flow of the contrast medium injected into the blood vessels of the patient. This system is intended for use in diagnostic and interventional procedures involving the cardiac blood vessels, abdominal blood vessels, and lower limb blood vessels.
Company Confidential
510(k): INFX-8000V with 56 Inch Monitor Page 15 of 736
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11. SUBSTANTIAL EQUIVALENCE:
The INFX-8000V with 56 inch Monitor is of comparable type and is substantially equivalent to the INFX-8000V (K081582).
12. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards. 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.
13. CONCLUSION
The INFX-8000V 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol in blue, with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba Medical Systems Corporation. Japan % Mr. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 94780
AUG 2 0 2013
Re: K112054
Trade/Device Name: INFX-8000V with 56 inch monitor Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified flouroscopic x-ray system Regulatory Class: II Product Code: JAA and IZI Dated: July 15, 2011 Received: July 19, 2011
Dear Mr. Biggins:
This letter corrects our substantially equivalent letter of August 5, 2011.
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
3
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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ין י
Indications for Use
510(k) Number (if known):
Device Name:
f
INFX-8000V with 56 inch monitor
Indications for Use:
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Prescription Use × (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 In Vitro Diagnostic Devices (OIVD)
Mary Sposta
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K112054
Page 1 of
Indication for Use Page 1 of 1
Company Confidontial JUL 2011
510(k): INFX-8000V with 56 inch Monitor Page 14 of 738