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K Number
K203703
Device Name
I-Q View
Manufacturer
First Source, Inc.
Date Cleared
2021-03-24

(96 days)

Product Code
MQBIZLLLZ
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This software is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, or lying in the prone or supine position and is intended for use in all routine radiography exams. The product is not intended for mammographic applications. This software is not meant for mammography, fluoroscopy, or angiography.
Device Description
The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol. The flat panel detector is not part of this submission. In the I-Q View software, the Digital Radiography Operator Console (DROC) software allows the following functions: - 1. Add new patients to the system; enter information about the patient and physician that will be associated with the digital radiographic images. - 2. Edit existing patient information. - 3. Emergency registration and edit Emergency settings. - 4. Pick from a selection of procedures, which defines the series of images to be acquired. - 5. Adiust technique settings before capturing the x-ray image. - 6. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations. - 7. Save an incomplete procedure, for which the rest of the exposures will be made at a later time. - 8. Close a procedure when all images have been captured. - 9. Review History images, resend and reprint images. - 10. Re-exam a completed patient. - 11. Protect patient records from being deleted by the system. - 12. Delete an examined Study with all images being captured. - 13. Edit User accounts. - 14. Check statistical information. - 15. Image QC. - 16. Image stitching. - 17. Provides electronic transfer of medical image data between medical devices.
More Information

K193644

K130883, K171353, K162687, K133139, K141440, K191813, K172007, K150929, K171137, K162552, K193017, K192400, K161730, K201043, K130936, K151465, K172793, K182348, K180332, K182533, K131483, K170113, K140551, K142698, K161942, K161966

No
The device description focuses on standard image acquisition, processing, and management functions typical of a digital radiography system. There is no mention of AI, ML, or related concepts in the provided text.

No.
The device is intended for generating and managing diagnostic radiographic images, not for providing therapy or treatment.

Yes

The "Device Description" section states that "It functions as a diagnostic x-ray image acquisition platform."

Yes

The device is described as a "software package" and its functions are entirely software-based, focusing on image acquisition, management, and transfer. It explicitly states that the flat panel detector (hardware) is not part of the submission.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states that this software is intended to generate and manage digital radiographic images of various body parts. It functions as an x-ray image acquisition platform.
  • Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on them. Its purpose is solely related to the acquisition and handling of medical images generated by an external imaging modality (digital radiography).

Therefore, this device falls under the category of medical imaging software, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

This software is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, or lying in the prone or supine position and is intended for use in all routine radiography exams. The product is not intended for mammographic applications.

This software is not meant for mammography, fluoroscopy, or angiography.

Product codes (comma separated list FDA assigned to the subject device)

MQB, IZL, LLZ

Device Description

The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol. The flat panel detector is not part of this submission. In the I-Q View software, the Digital Radiography Operator Console (DROC) software allows the following functions:

    1. Add new patients to the system; enter information about the patient and physician that will be associated with the digital radiographic images.
    1. Edit existing patient information.
    1. Emergency registration and edit Emergency settings.
    1. Pick from a selection of procedures, which defines the series of images to be acquired.
    1. Adjust technique settings before capturing the x-ray image.
    1. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
    1. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
    1. Close a procedure when all images have been captured.
    1. Review History images, resend and reprint images.
    1. Re-exam a completed patient.
    1. Protect patient records from being deleted by the system.
    1. Delete an examined Study with all images being captured.
    1. Edit User accounts.
    1. Check statistical information.
    1. Image QC.
    1. Image stitching.
    1. Provides electronic transfer of medical image data between medical devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

digital radiographic images

Anatomical Site

skull, spinal column, extremities, and other body parts; skull, spinal column, chest, abdomen, extremities, and other body parts

Indicated Patient Age Range

all ages

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)

Bench Testing was conducted via verification and validation. Testing was done to demonstrate the intended functions and the relative performance of the I-Q View software. Integration testing was done to verify that the compatible solid-state detectors listed in the Comparison Table above, performed within specification and as intended. Non-clinical test results have confirmed that the software/device performs to specification and that the submitted I-Q View software is as safe and as functionally effective as the predicate software.

The bench testing is significant enough to demonstrate that the I-Q View software is as good as the predicate software. All features and functionality have been tested and all specifications have been met. Therefore, it is our conclusion that clinical testing is not required to show substantial equivalence.

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.

K193644

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.

K130883, K171353, K162687, K133139, K141440, K191813, K172007, K150929, K171137, K162552, K193017, K192400, K161730, K201043, K130936, K151465, K172793, K182348, K180332, K182533, K131483, K170113, K140551, K142698, K161942, K161966

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

March 24, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

First Source, Inc. % Ms. Susan Ryan-Kron Quality & Regulatory Manager 3495 Winton Place, Bldg. E, Ste 1 ROCHESTER NY 14623

Re: K203703

Trade/Device Name: I-O View Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, IZL, LLZ Dated: February 5, 2021 Received: February 8, 2021

Dear Ms. Ryan-Kron:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

1

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203703

Device Name I-Q View

Indications for Use (Describe)

This software is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, or lying in the prone or supine position and is intended for use in all routine radiography exams. The product is not intended for mammographic applications.

This software is not meant for mammography, fluoroscopy, or angiography.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary I-Q View (K203703)

Company Name:First Source, Inc.
Address:3495 Winton Place
Bldg E, Ste 1
Rochester, NY 14623
Telephone No:585.272.1690
Registration No.:3004063527
Contact person:Susan Ryan-Kron
Date Prepared:February 5, 2021
Trade/Device Name:I-Q View
Classification Name:Stationary X-ray System
DR Regulation No.:21 CFR 892.1680
Regulatory Name:Stationary x-ray system
Classification Panel:Radiology
Regulation Class:Class II
Product Code:MQB, IZL, LLZ

Predicate:

K number: K193644 Company Name: LiverMoreTech, Inc. Trade/Device Name: E-COM DR-2000 DR DR Regulation Number: 21 CFR 892.1680 Requlation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB

Device description:

The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol. The flat panel detector is not part of this submission. In the I-Q View software, the Digital Radiography Operator Console (DROC) software allows the following functions:

    1. Add new patients to the system; enter information about the patient and physician that will be associated with the digital radiographic images.
    1. Edit existing patient information.
    1. Emergency registration and edit Emergency settings.

4

    1. Pick from a selection of procedures, which defines the series of images to be acquired.
    1. Adiust technique settings before capturing the x-ray image.
    1. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
    1. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
    1. Close a procedure when all images have been captured.
    1. Review History images, resend and reprint images.
    1. Re-exam a completed patient.
    1. Protect patient records from being deleted by the system.
    1. Delete an examined Study with all images being captured.
    1. Edit User accounts.
    1. Check statistical information.
    1. Image QC.
    1. Image stitching.
    1. Provides electronic transfer of medical image data between medical devices.

Indications for Use (intended use):

This software is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams. The product is not intended for mammographic applications.

This software is not meant for mammography, fluoroscopy, or angiography.

Technological Characteristics:

The I-Q View has the same technological characteristics (e.g. design) as the predicate software. Specifications are essentially the same or similar and there is no impact to the safety nor effectiveness of the diagnostic image quality as a result of this I-Q View software.

Comparison Table:

A comparison chart provides the similarities and differences of technical features of the predicate software and the software for this submission.

| Characteristics | Predicate: LiverMoreTech
E-COM DR-2000 (K193644) | I-Q View
This submission |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Intended for digital image capture use
in general radiographic examinations,
wherever convention screen-film
systems may be used, excluding | This software is intended to generate
digital radiographic images of the
skull, spinal column, chest, abdomen,
extremities, and other body parts in |
| | fluoroscopy, angiography and
mammography. The kit allows imaging
of the skull, chest, shoulders, spine,
abdomen, pelvis, and extremities. | patients of all ages. Applications can
be performed with the patient sitting,
standing, or lying in the prone or
supine position and is intended for
use in all routine radiography exams.
This software is not meant for
mammography, fluoroscopy, or
angiography. |
| Platform | Windows 10 | Windows 10 |
| Compatible
solid-state
receptors | Toshiba FDX4343R Detector
(K130883)
Toshiba FDX3543RP Detector
(K130883)
Toshiba FDX3543RPW Detector
(K171353)
Toshiba FDX2530RPW Detector
(K162687)
Toshiba FDX4343RPW Detector
(K162687)
Thales Pixium RAD 4143 Detector
(K133139)
Thales Pixium RAD 4343 Detector
(K133139)
Thales Pixium RAD 3543 Detector
(K141440)
Thales Pixium RAD 3543EZ Detector
(K141440)
Thales Pixium RAD 2430EZ Detector
(K141440)
Thales Pixium RAD 3543DR Detector
(K191813)
Varian PaxScan 4336R Detector
(K172007)
Varian PaxScan 4343R Detector
(K172007)
Varian PaxScan 4336X Detector
(K172007)
Varian PaxScan 4336W Detector
(K172007) | Toshiba FDX4343R Detector
(K130883)
Toshiba FDX3543RP Detector
(K130883)
Toshiba FDX3543RPW Detector
(K171353)
Toshiba FDX2530RPW Detector
(K162687)
Toshiba FDX4343RPW Detector
(K162687)
Thales Pixium RAD 4143 Detector
(K133139)
Thales Pixium RAD 4343 Detector
(K133139)
Thales Pixium RAD 3543 Detector
(K141440)
Thales Pixium RAD 3543EZ Detector
(K141440)
Thales Pixium RAD 2430EZ Detector
(K141440)
Thales Pixium RAD 3543DR Detector
(K191813)
Varian PaxScan 4336R Detector
(K172007)
Varian PaxScan 4343R Detector
(K172007)
Varian PaxScan 4336X Detector
(K172007)
Varian PaxScan 4336W Detector
(K172007)
Careray - 1500Cw (K150929)
DRTech - ExprimerEVS2430
(K171137),
EVS3643 (K162552),
EVS4343W (K193017),
EVS4343A (K192400)
iRay - Mars 1417V (K161730),
1717V (K201043)
Konica Minolta - AeroDR 1210HQ
(K130936) |

5

6

| DICOM 3.0
compatibility | Yes | 1417HQ/HD (K151465),
1717HQ (K172793)

LG – DXD 1417 (K182348),
17HK700G (K180332)

Pixxgen - PIXX1212 (K182533),
PIXX1417 (K182533),
PIXX1717 (K182533)

Thales - Pixium RAD 4143RC/RG
(K131483),
4343RC/RG (K131483),
Pixium RAD 4343RC-E/RG-E
(K170113),
Pixium RAD 3543DR-X (K170113)

Varex - XRpad 4336 (K140551),
4343F (K142698),
XRpad2 3025 (K161942),
4336 (K161966) |
|----------------------------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Yes | | |

Bench Testing:

Bench Testing was conducted via verification and validation. Testing was done to demonstrate the intended functions and the relative performance of the I-Q View software. Integration testing was done to verify that the compatible solid-state detectors listed in the Comparison Table above, performed within specification and as intended. Non-clinical test results have confirmed that the software/device performs to specification and that the submitted I-Q View software is as safe and as functionally effective as the predicate software.

Clinical Testing:

The bench testing is significant enough to demonstrate that the I-Q View software is as good as the predicate software. All features and functionality have been tested and all specifications have been met. Therefore, it is our conclusion that clinical testing is not required to show substantial equivalence.

Conclusion:

The First Source, Inc. I-Q View does not introduce any new indications for use, nor does the use of the software result in any new potential hazards. First Source, Inc. considers the I-Q View digital imaging acquisition software to be substantially equivalent with the predicate with respect to safety and effectiveness.