(14 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard x-ray technology components.
No
The device is described as a "diagnostic x-ray angiography system" used for "diagnostic and interventional procedures," and its primary function is to "obtain fluoroscopy or radiography images of the body." These functions are for diagnosis and image guidance, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system" and "This x-ray angiography system is used for diagnostic and interventional procedures". It also mentions "This system is indicated for use in diagnostic and angiographic procedures".
No
The device description explicitly lists hardware components such as a computer system, support arms (containing the tube and detector), x-ray generator, and a patient table, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "digital x-ray system configured for use as a diagnostic x-ray angiography system." It is used for "diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities." This involves imaging the body directly using x-rays.
- Device Description: The description details the components of an x-ray system (computer system, support arms, tube, detector, generator, patient table).
- Input Imaging Modality: The input is explicitly stated as "x-rays."
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device operates on the body using external radiation (x-rays) to create images.
N/A
Intended Use / Indications for Use
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
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)
90MQB, JAA, MOB
Device Description
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray, digital x-ray, fluoroscopy, radiography
Anatomical Site
cardiac blood vessels, cerebral blood vessels, abdominal blood vessels, lower extremities, heart, brain, abdomen
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.
GE Innova 4100; 510(k) Control # K052412, Toshiba DFP-8000D/FPD; 510(k) Control # K052884
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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K081621
pg. 1 of 2
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000C
510(k) Summary
| Date: | June 3, 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 Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | INFX-8000C (Infinix CCi and Infinix VCi) |
| Common Name: | Electrostatic Fluoroscopic x-ray System) |
| [Fed. Reg. No. 892.1650, Pro. Code: 90MQB] | |
| Regulatory Class: | II (per 21 CFR 892.1650) |
| Performance Standard: | 21 CFR Subchapter J, |
| Federal Diagnostic X-ray Equipment Standard | |
| Predicate Device(s): | GE Innova 4100; 510(k) Control # K052412 |
| Toshiba DFP-8000D/FPD; 510(k) Control # K052884 | |
| Reason For Submission | Model Number Change |
Description of this Device:
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table.
Summary of Intended Uses:
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
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K081621
Pg. 2 of 2
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000C
Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate fluorosonois. and radiographic images of the anatomy.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as All requirements of the Federal Diagnostic Equipment outlined in 21 CFR § 820. 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:
r
The INFX-8000V is of comparable type and substantially equivalent to:
GE Innova 4100; 510(k) Control # K052412 Toshiba DFP-8000D/FPD; 510(k) Control # K052884
Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo includes the department's seal on the left, which features an abstract design of human figures. To the right of the seal, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" 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
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
AUG 2 1 2013
Re: K081621
Trade/Device Name: INFX-8000C; Infinix-CCí and Infinix-VCí Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and MOB Dated: June 6. 2008 Received: June 9, 2008
Dear Mr. Job:
This letter corrects our substantially equivalent letter of June 23, 2008.
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 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
4
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000C
Indications for Use
108162 510(k) Number (if known):
INFX-8000C; Infinix-CCi and Infinix- VCi Device Name:
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 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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Aoni In Whang
(Division Sign-Off)
Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number