The DRS system of the "Uniscan" model is a stationary general-purpose diagnostic (universal) system for obtaining standard planar X-ray images of the bone structure and soft tissues of a patient in the standing, sitting and lying position.
The DRS system of the "Pulmoscan" model is a stationary specialized-purpose diagnostic system for mass examination (screening) of wide groups of population, first of all, in polyclinics at the stage of before-doctor examination with the purpose of early diagnostics of the thorax organs.
The DRS system of the "Pulmoscan-T" model is a mobile specialized-purpose diagnostic system, particularly, for mass examination (screening) of wide groups of population directly at the places of their maximum concentration (in educational institutions and at enterprises), in remote areas (villages, military units), in institutions with the special access regime (refugees camps, penal jurisdiction) with the purpose of early diagnostics of the thorax organs.

Device Description

The principal of functioning of the DRS system is based on:

generation of highly stable low-energy X-ray radiation (from 40 up to 150 keV) with controllable parameters (voltage, current, time, exposure duration) by means of an X-ray source connected to the X-ray power supply unit;
formation of a flat narrow with the width D fan-shaped X-ray beam with the possibility of masking according to the radiation angle a by means of the adjustable diaphragm;
adjustment of the area of the patient's body to be examined (input dimensions A B) by scanning with a flat X-ray beam in the field of the scanning angle b with the possibility of specifying and visual control of the scanning (exposure) field;
magnification of the planar X-ray image of the patient with the specified enlargement by projecting it to the scanning X-ray detector located at a considerable distance from the patient;
obtaining the digital X-ray image of the area to be examined by means of the scanning X-ray detector (on the basis of a linear matrix multiclement semiconductor detector), converting the absorbed X-ray radiation into digital form;
formation of the two-dimensional digital projection image on the computer monitor with the possibility of manipulation and archiving by means of the special software

AI/ML Overview

The acceptance criteria for the "Pulmoscan," "Uniscan," and "Pulmoscan-T" Digital Radiographic Systems are not explicitly detailed in the provided text as specific performance metrics and their corresponding thresholds. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on intended use, performance standards, and electrical safety.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the acceptance criteria are met by demonstrating similarity to the predicate device, the Siemens Multix FD and Thorax FD Stationary X-Ray System (K983732).

Characteristic	Acceptance Criteria (Predicate Device K983732)	Reported Device Performance ("Pulmoscan," "Uniscan," and "Pulmoscan-T")
Intended Use:	Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.	SAME
Performance Standard	21 CFR 1020.30	SAME
Electrical safety	Electrical Safety per Underwriters Laboratories Standard UL-2601(IEC-60601) and IEC 60601, Underwriters Laboratories Standard UL187: UL Standard for Safety for X-Ray Equipment, CE Marking Requirements	SAME

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "bench and user testing" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document states "user testing" but does not specify the number or qualifications of experts involved in establishing ground truth for the test set. Given the nature of the submission for substantial equivalence based on technical specifications and safety rather than a clinical performance study with diagnostic endpoints, a formal "ground truth" establishment by experts in the typical sense of AI/diagnostic device validation studies is not described.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1) for establishing ground truth is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to a predicate device, not on comparing performance with and without AI assistance or evaluating human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device is an X-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable in this context. The device's performance is inherently tied to its function as a diagnostic imaging system operated by trained personnel.

7. The Type of Ground Truth Used:

Given that this is a 510(k) submission for an X-ray system relying on substantial equivalence, the "ground truth" typically refers to the established safe and effective performance of the predicate device. The new device is deemed acceptable because it performs equivalently on safety and technical characteristics. There is no mention of ground truth established through expert consensus, pathology, or outcomes data in the context of a new diagnostic claim.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a radiographic system, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable, as there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is summarized as "bench and user testing." The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices."

The conclusion further reiterates: "After analyzing both bench and user testing data, it is the conclusion of Medlink Imaging that the 'Pulmoscan,' 'Uniscan,' and 'Pulmoscan-T' Radiographic Systems are as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

While the details of these tests are not provided in the summary, they would have focused on verifying that the "Pulmoscan," "Uniscan," and "Pulmoscan-T" systems met the same technical specifications, safety standards (21 CFR 1020.30, UL standards, IEC standards), and produced images comparable in quality and diagnostic utility to the Siemens Multix FD and Thorax FD systems.

Summary

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MAR 1 8 2005

EXHIBIT 2 Medlink Imaging Inc. 200 Clearbrook Rd Elmsford NY 10523 Tel 800-456-7800 Fax 888-437-9729 September 30, 2003 Contact: John Ciarcia

K073577

510(k) Summary

l. Identification of the Devices: ruentification of the Devices.
Proprietary-Trade Name: "Pulmoscan," "Uniscan," and "Pulmoscan-T" Digital Radiographic Systems Classification Name: Stationary X-Ray System, Product Code KPR and MKP Common/Usual Name: Stationary or Transportable X-Ray System

1. Equivalent legally marketed devices This product is similar in function to the Siemens Multix FD and Thorax FD Stationary X-Ray System (K983732)
1. Indications for Use (intended use) The "Uniscan" model is a stationary general-purpose diagnostic (universal) system for obtaining standard planar X-ray images of the bone structure and soft tissues of a patient in the standing, sitting and lying position .

and Tyng Position :

The "Pulmoscan" model is a stationary specialized-purpose diagnostic system for mass examination (screening) of wide groups of population, first of all, in polyclinics at the stage of before-doctor examination with the purpose of early diagnostics of the thorax organs.

Giagnostics of the thorax organs.

The "Pulmoscan-T" model is a mobile specialized-purpose diagnostic system, particularly, for mass examination (screening) of wide groups of population directly at the places of their maximum concentration (in educational institutions and at cnterprises), in remote areas (villages, military units), in institutions with the special access regime (refugees camps, penal jurisdiction) with the purpose of early diagnostics of the thorax organs.
1. Description of the Device: The principal of functioning of the DRS system is based on:
generation of highly stable low-energy X-ray radiation (from 40 up to 150 keV) with controllable parameters (voltage, current, time, exposure duration) by means of an X-ray source connected to the X-ray power supply unit;
formation of a flat narrow with the width D fan-shaped X-ray beam with the possibility of masking according to the radiation angle a by means of the adiustable diaphragm;

adgustere of the area of the patient's body to be examined (input dimensions A B) by scanning with a flat X-ray beam in the field of the scanning angle b with the possibility of specifying and visual control of the scanning (exposure) field; - magnification of the planar X-ray image of the patient with the specified enlargement by projecting it to the scanning X-ray detector located at a

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K0 33577

considerable distance from the patient;

obtaining the digital X-ray image of the area to be examined by means of the scanning X-ray detector (on the basis of a linear matrix multiclement semiconductor detector), converting the absorbed X-ray radiation into digital form;
formation of the two-dimensional digital projection image on the computer monitor with the possibility of manipulation and archiving by means of the special software
1. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

Characteristic	Siemens Multix FD andThorax FD Stationary	"Pulmoscan," "Uniscan,"and "Pulmoscan-T"
	X-Ray System(K983732)	Radiographic Systems
Intended Use:	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.	SAME
Performance Standard	21 CFR 1020.30	SAME
Electrical safety	Electrical Safety perUnderwriters LaboratoriesStandard UL-2601(IEC-60601) and IEC 60601,Underwriters LaboratoriesStandard UL187: ULStandard for Safety for X-Ray Equipment, CEMarking Requirements	SAME

1. Substantial Equivalence Chart, "Pulmoscan," "Uniscan," and "Pulmoscan-T" Radiographic Systems

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Medlink Imaging that the "Pulmoscan," "I Iniscan," and "Pulmoscan-T" Radiographic Systems are as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font. The logo is simple and professional, and it is easily recognizable.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Medlink Imaging, Inc. % Daniel Kamm, P.E. Regulatory Affairs Kamm & Associates PO Box 7007 DEERFIELD IL 60015

AUG 2 1 2013

Re: K033577

Trade/Device Name: "Pulmoscan", "Uniscan", and "Pulmoscan-T" Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray System Regulatory Class: II Product Code: KPR and MOB Dated: February 3, 2005 Received: February 22, 2005

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of March 18, 2005.

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

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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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i) Indications for Use

510(k) Number_K0335772_

Device Name: "Pulmoscan," "Uniscan," and "Pulmoscan-7" Radiographic Systems

Indications for Usc:

Indications for Use:

The DRS system of the "Uniscan" model is a stationary general-purpose diagnostic - The DRS system of the "Uniscal" model is a stationaly general particular particure and
(universal) system for obtaining standard planar X-ray images of the bone structure a (universal) system for obtaining saining, sitting and lying position

soft tissues of a patient in the standing, sharty and 15 mg procialized-purpose

The DRS system of the "Pulmoscan" model is a stationary specialized-purpose - The DRS system of the "Pumpsean Intount is a stations of population, first of
diagnostic system for mass examination (screening) of with purpose of carly diagnostic system for mass examination (sereching) of theo group.
all, in polyclinics at the stage of before-doctor examination with the purpose of carly diagnostics of the thorax organs.

diagnostics of the thorax organs.

The DRS system of the "Pulmoscan-T" model is a mobile specialized-purpose . The DRS system of the "Pumoscan-1" model is a moone operation of wide groups of
diagnostic system, particularly, for mass examination (screening) in educational diagnostic system, particularly, for their maximum concentration (in cducational
population directly at the places of their maximum concentration (in educational), in institu population directly at the places of them institutions military units), in institutions
institutions and at enterprises), in remote areas (virdiction) with the purpose of institutions and at enterprises), in remote areas (Vinages) million with the purpose of early diagnostics of the thorax organs.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
------------------	---------------------------------------------------

Over the Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K033577

Page 8 of 978

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.