(491 days)
Not Found
No
The provided text describes a standard X-ray system and its operational principles, focusing on hardware components and image acquisition. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or other sections. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a "stationary general-purpose diagnostic (universal) system for obtaining standard planar X-ray images" and "diagnostic system for mass examination (screening)". Its purpose is to obtain images for early diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the DRS system models are "general-purpose diagnostic (universal) system" or "specialized-purpose diagnostic system" for obtaining X-ray images for diagnostic purposes, including "early diagnostics of the thorax organs."
No
The device description explicitly details hardware components such as an X-ray source, power supply unit, adjustable diaphragm, and a scanning X-ray detector, indicating it is a hardware-based system with accompanying software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for obtaining standard planar X-ray images of the bone structure and soft tissues of a patient, and for mass examination (screening) of the thorax organs. This involves imaging the patient directly.
- Device Description: The description details the generation and detection of X-ray radiation passing through the patient's body to create an image. This is a direct imaging process, not an in vitro test.
- Anatomical Site: The anatomical sites mentioned are parts of the human body (bone structure, soft tissues, thorax organs, etc.). IVD devices typically analyze samples taken from the body (blood, urine, tissue, etc.).
- Input Imaging Modality: The input modality is X-ray, which is a form of medical imaging performed on a living subject.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device operates by imaging the patient directly using X-rays.
N/A
Intended Use / Indications for 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.
- 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 "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.
Product codes
KPR, MKP, MOB
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 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
bone structure, soft tissues, skull, spinal column, chest, abdomen, extremities, other body parts, thorax organs
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
qualified/trained doctor or technician, polyclinics, educational institutions, enterprises, remote areas (villages, military units), institutions with the special access regime (refugees camps, penal jurisdiction)
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 and user testing indicates that the new device is as safe and effective as the predicate devices.
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
§ 892.1680 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
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
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
-
- Equivalent legally marketed devices This product is similar in function to the Siemens Multix FD and Thorax FD Stationary X-Ray System (K983732)
-
- 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.
-
- 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
1
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
-
- 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 and
Thorax FD Stationary | "Pulmoscan," "Uniscan,"
and "Pulmoscan-T" |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | X-Ray System
(K983732) | Radiographic Systems |
| 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 |
-
- 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.
2
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
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
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 | ✓ |
|---|---|
| ------------------ | --------------------------------------------------- |
OR
| Over the Counter Use | |
|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K033577 |
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