Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary focuses on hardware modifications (battery power) and adherence to electrical and safety standards. There is no mention of AI, ML, or any algorithms beyond basic image processing for DICOM output.

Therapeutic

No.
The device is indicated for use in general radiographic images of human anatomy and is for diagnostic purposes, not therapeutic.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states that the device is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "digital radiography system, featuring an integrated flat panel digital detector (FPD)" and mentions adding "battery power capability to the devices," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states it's for "general radiographic images of human anatomy" and is intended to "replace radiographic film/screen systems." This describes a device used for in vivo imaging (imaging within the living body), not for testing samples in vitro (outside the body).
Device Description: The description reinforces this by stating it's a "digital radiography system" featuring a "flat panel digital detector (FPD)" designed to "perform digital radiographic examinations."
Input Imaging Modality: The input modality is X-Ray, which is used for imaging the body directly.
Anatomical Site: The anatomical site is "human anatomy," indicating it's used on the body.

IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

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

MOB

Device Description

The PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features. The modification involves adding battery power capability to the devices in our previous submission K180976.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

human anatomy

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)

Bench testing was conducted to evaluate electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2), and battery safety (IEC 62133 Ed 2.0). Risk Analysis was conducted in accordance with ISO 14971:2012 and EN 62304. MTF and DQE measurements were not needed because the panel characteristics are identical to the predicate device. Battery life testing confirmed that the PIXX 1212 runs for 8 hours/480 images and the PIXX 1717/1417 for 5 hours/300 images. Clinical images were not required because the panel technology did not change from the predicate device.

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.

K180976

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 4, 2018

Pixxgen Corporation % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K182533

Trade/Device Name: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: September 12, 2018 Received: September 14, 2018

Dear Daniel Kamm:

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

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hol 2. Nils

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182533

Device Name

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels

Indications for Use (Describe)

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications

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 510(k) Number K182533 PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14056, Korea Tel +82.70.4846.8888 Date Prepared: September 28, 2018 Contact: Young Kim, President

1. Identification of the Device:
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Device Class:

Proprietary-Trade Names: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Device: Solid State X-Ray Imager (Flat Panel/Digital Imager) Regulation Name: Stationary x-ray system. Product Code: MQB Regulation Number: 892.1680

1. Equivalent legally marketed device: PIXX 1717; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels.

Manufacturer:	PIXXGEN Corporation
510(k) Number:	K180976
Device:	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Name:	Stationary x-ray system.
Product Code:	MQB
Regulation Number:	892.1680
Device Class:	2

1. Indications for Use (intended use) Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, and mammographic applications. (Rx Only)

4. Description of the Device:

The PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features. The modification involves adding battery power capability to the devices in our previous submission K180976.

1. Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory results indicates that the new devices are as safe and effective as the predicate devices.

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6. Substantial Equivalence Chart

| | K180976, PIXX 1717,
PIXX 1417, PIXX 1212 | PIXX 1717 | PIXX 1417 | PIXX 1212 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | Indicated for use in general
radiographic images of human
anatomy. It is intended to
replace radiographic film/screen
systems in all general-purpose
diagnostic procedures, excluding
fluoroscopic, angiographic, and
mammographic applications | UNCHANGED | UNCHANGED | UNCHANGED |
| Configuration | This submission is for the
Digital Panel and Software
only, no generator or stand
provided. | UNCHANGED | UNCHANGED | UNCHANGED |
| Pixel Pitch | 140um | SAME | SAME | SAME |
| Limiting
Resolution | Over 3 lp/mm | SAME | SAME | SAME |
| DQE(CSI) | At 2 lp/mm 26.5% | SAME | SAME | SAME |
| MTF(CSI) | At 2 lp/mm 44% | SAME | SAME | SAME |
| DQE(GOS) | At 2 lp/mm 21 | SAME | SAME | SAME |
| MTF(GOS) | At 2 lp/mm 35% | SAME | SAME | SAME |
| DQE and MTF
Comments | Adding battery power capability did not change the panel performance. | | | |
| A/D Conversion | 16 bits | SAME | SAME | SAME |
| Active Area | 17 x 17 inch
14 x 17 inch
12 x 12 inch | 17 x 17 inch | 14 x 17 inch | 12 x 12 inch |
| Dimensions(m
m)/
Weights(Kg) | 460(W)x461(L)x15(H)/3.0Kg
385(W) x 460(L) x 15(H)/
2.8Kg
308.5(W) x 319.5(L) x 15(H)/
1.9Kg | SAME | SAME | SAME |
| Pixels | 3,072x3,072
2,560 x 3,072
2,048 x 2,048 | 3,072 x 3,072 | 2,560 x 3,072 | 2,048 x 2,048 |
| Software | Outputs a DICOM image | SAME | SAME | SAME |
| DICOM | Yes | Yes | Yes | Yes |
| Scintillator | Csl orGOS | UNCHANGED | UNCHANGED | UNCHANGED |
| Interface | Wired: Gigabit Ethernet
(1000BASE-T)
Wireless:IEEE802.11ac,
backward compatible | SAME | SAME | SAME |
| Power source | AC Line only | AC Line and/or
Rechargeable Lithium
Battery;
5 hours/300 images | AC Line and/or
Rechargeable
Lithium Battery;
5 hours/300 images | AC Line and/or
Rechargeable Lithium
Battery 8 hours/480
images |
| | K180976, PIXX 1717,
PIXX 1417, PIXX 1212 | PIXX 1717 | PIXX 1417 | PIXX 1212 |
| Standards | Electrical Safety per IEC
60601-1:2012 and EMC per
IEC 60601-1-22007+AC:2010
as well as IEEE802.11ac.
Meets FCC requirements. | SAME plus IEC 62133
Battery safety | SAME plus IEC 62133
Battery safety | SAME plus IEC 62133
Battery safety |

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1. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility, and Battery Safety Tests. Standards met:
  Electrical safety per: IEC/UL 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety. (General)

Electromagnetic Compatibility per IEC 60601-1-2, Collateral Standard: Electromagnetic compatibility Requirements and tests.

IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other nonacid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications

Risk Analysis was conducted in accordance with ISO 14971:2012 and EN 62304. The software remains the same as in K180976. MTF and DQE measurements were not needed because the panel characteristics are identical to our predicate cleared earlier this year.

Battery life testing was conducted to confirm that the PIXX 1212 runs for 8 hours/480 images and for the PIXX 1717/1417 for 5 hours/300 images.

Cybersecurity precautionary labeling was added per the FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Document Issued on: October 2, 2014.

1. Summary of Clinical Testing: Clinical images were not required because the panel technology did not change from K180976.
1. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Pixxgen that the PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels are as safe and effective as the predicate device, have few technological differences, and has the identical indications for use, thus rendering them substantially equivalent to the predicate device.