(167 days)
Not Found
No
The summary mentions "Image processing algorithms" but does not provide any details suggesting the use of AI or ML techniques. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
No
The device is an imaging system used for diagnosis, not for treating conditions or performing therapy.
Yes
The device is intended to acquire, display, and process images, and "Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques," indicating its use in aiding diagnosis.
No
The device description explicitly lists hardware components such as an "X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A), computer, monitor, and the digital imaging system." This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for acquiring, displaying, processing, and managing digital X-ray images. This is related to medical imaging of the human body, not testing samples taken from the body (which is the core of IVD).
- Device Description: The description focuses on the components of an X-ray imaging system (image receptor, computer, monitor, software). It does not mention any reagents, calibrators, controls, or other components typically associated with IVD devices.
- Input Imaging Modality: The input is Digital X-ray, which is an imaging modality used to visualize internal structures of the body, not to analyze biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device is used for direct imaging of the patient's body using X-rays.
N/A
Intended Use / Indications for Use
The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i3 TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography). .
For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Product codes
JAA, OWB, MOB, IZI
Device Description
The InfiMed is TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5 TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.
The InfiMed i5 TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A), computer, monitor, and the digital imaging system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
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)
Non-clinical Tests Discussion:
Validation was completed in accordance with the Validation Protocol included with this submission. This protocol was designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the is TM Digital X-ray Imaging System is as safe and effective as the predicate devices.
Clinical Tests Discussion:
Clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm073781.pdf.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logo for INFIMED. The logo consists of a stylized graphic to the left of the word "INFIMED". The graphic appears to be a geometric shape with a curved line above it. The word "INFIMED" is in a bold, sans-serif font.
Kc93066
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Section 3: 510(k) Summary
Date Prepared:
09/29/2009
Contact Person:
Catherine Mulcahy Quality Assurance Manager MAR 1 3 2010
Telephone: Fax:
315-453-4545 x288 315-453-4550
Submitter Name:
InfiMed. Inc. 121 Metropolitan Drive Liverpool, NY 13088
Device Trade Name:
Common Name:
Digital X-ray Imaging System
i5 TM Digital X-ray Imaging System
Classification Name(s):
Image-intensified fluoroscopic X-ray system Solid State X-ray Imaging Device
Predicate Devices: Orion Fluoroscopic Imaging System StingRay DR
510(k) Number: K012490 K992794
Product Codes: JAA, OWB MQB .
Product Codes: JAA MOB
Device Description:
The InfiMed is TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i5 TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.
The InfiMed i5 TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A), computer, monitor, and the digital imaging system.
Intended Use:
The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic
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Image /page/1/Picture/0 description: The image shows the logo for INFIMED. The logo consists of a stylized diamond shape with a curved line above it, followed by the word "INFIMED" in bold, sans-serif font. The logo is black and white.
KC93066
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details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i3 TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i5 TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography). .
For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Technological Characteristics Comparison:
The i- TM Digital X-ray Imaging System supports the same modalities as the predicate devices with the same components or imaging concepts, and delivers equivalent or better image quality as the predicate devices. The comparison chart reveals that functions performed by the predicate devices are performed by the i5 TM Digital X-ray-Imaging System. The is TM Digital X-ray Imaging System has a number of additional features including the ability to interface with a variety of image receptors from CCD cameras to commercially available SSXIs. Therefore, the i- TM Digital X-ray Imaging System is substantially equivalent to the predicate devices.
Non-clinical Tests Discussion:
Validation was completed in accordance with the Validation Protocol included with this submission. This protocol was designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the is TM Digital X-ray Imaging System is as safe and effective as the predicate devices.
Clinical Tests Discussion:
Clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm073781.pdf.
Conclusion:
Based upon the results of Verification and Validation testing, the InfiMed if TM Digital Xray Imaging System has no new indications for use, has no significant technological differences, and is as safe and effective as, and therefore substantially equivalent to the above listed current legally marketed predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo includes a symbol with three stylized human figures in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the symbol. The overall design is clean and professional.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
InfiMed. Inc % Mr. Jigar Shah 55 Northern Boulevard, Suite 200 GREAT NECK, NEW YORK 11021
JUL 30 2012
Re: K093066
Trade/Device Name: i3TM Digital X-ray Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, MOB and IZI Dated: March 9, 2010 Received: March 11. 2010
Dear Mr. Shah:
This letter corrects our substantially equivalent letter of March 13, 2010.
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. Iisting 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
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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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Image /page/4/Picture/0 description: The image shows the word "INFIMED" in bold, sans-serif font. To the left of the word is a logo that appears to be a stylized, geometric shape. The logo is black and white and has a three-dimensional appearance. The word "INFIMED" is written in all capital letters.
Section 2: Indications for Use
510(k) Number (if known):
Ko93066
Device Name: is TM Digital X-ray Imaging System
Indications for Use:
The InfiMed i5 TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i TM Digital X-70x Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The if TM Digital X-ray Imaging System has the billity to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image recentor, camputer, monitor and imaging software.
For the DR application, the InfiMed is TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy). angiography, and mammography).
For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imming procedures are performed.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
JHA
510K K093066
121 Metropolitan Park Drive, Liverpool, New York 13088 K093066 Supplement 2 - Appendix E Page 1 of 4