K Number

Device Name

FLAATZ 500

Manufacturer

DRTECH CORP.

Date Cleared

2009-07-01

(15 days)

Product Code

KPR

Regulation Number

892.1680

Intended Use

The FLAATZ 500 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammography applications).

Device Description

The FLAATZ 500 is a radiographic Image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The FLAATZ 500 system Includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains for image data capture and correction of defects on the image data.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K080064

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on image acquisition and basic correction, with no mention of AI/ML terms or functionalities like automated analysis or interpretation.

Therapeutic

No.
The device is indicated for generating radiographic images and image acquisition, which are diagnostic functions, not therapeutic.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for use in "general purpose diagnostic procedures." The "Device Description" also mentions it is a "radiographic Image acquisition device."

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a Detector Panel, Control Box, Switch Box, and Interconnecting Cables, in addition to the API (software).

IVD (In Vitro Diagnostic)

Based on the provided information, the FLAATZ 500 is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is clearly stated as "generating radiographic images of human anatomy" for "general purpose diagnostic procedures." This involves imaging the internal structures of the body using X-rays, which is an in vivo (within the living body) process, not in vitro (outside the living body, typically involving samples like blood or tissue).
Device Description: The description details a system for acquiring radiographic images, including a detector panel that absorbs X-ray photons. This aligns with medical imaging, not laboratory testing of samples.
Input Imaging Modality: The input modality is "radiographic," which is a form of medical imaging.
Anatomical Site: The anatomical site is "human anatomy," further indicating imaging of the body.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment. The FLAATZ 500 does not perform this function. It is a medical imaging device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FLAATZ 500 is indicated for use in generating radiographic images of human analomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammographic applications).

Product codes

KPR

Device Description

The FLAATZ 500 is a radiographic Image acquisition device. It is a fully integrated limage capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The ELAATZ: 500 system Includes a Detector Panel, Control Box, Switch Box, Unterconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in wrich the input x-ray photons are absorbed in an a-Sellayer: The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power.to the Detector-Panel. The Switch Box transfers: signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED tights. Finally, the API contains for image data capture and correction of defects on the image data.

Mentions image processing

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

technician in a typical radiology environment.

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)

The FLAATZ 500 has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devises" and has shown good performance, substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K080064

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K091747

510(k) Summary

JUL - 1 2009

Submitter

DRTECH Corporation 333-1 Sangdaewon1 Dong, Seongnam City Gyeonggi-do, Korea (462-807) www.drtech.co.kr

Contact Person

...

Date Prepared ::

Device Name

Reason for Submission
Classification
Product Code
Predicate Device

New Device

May 25, 2009

FLAATZ 500

Baom Jin Moon Vice President bimgon@drtech.co.kr + 82-31-730-6800

21 CFR 6892 1680

FLAATZ 750 DRTECH Corporation

510(k) No :: K080064

Device Description

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12, Conclusion

The FLAATZ 500 is substantially equivalent to the Predicate Device in design and performance

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DRTECH Corporation % Mr. Marc M. Mouser CAS Manager II/Office Coordinator Underwriters Laboratories. Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K091747

Trade/Device Name: FLAATZ 500 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 1, 2009 Received: June 16, 2009

Dear Mr. Mouser:

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use Statement

510(k) Number (if known):

K091747

Device Name: FLAATZ 500

Indications for Use

The FLAATZ 500 is indicated for use in generating radiographic 100 a 0 le s anatomy. It is intended to replace radiographic film/screen systems in all purpose diagnostic procedures (excluding fluoroscopic, anglograph mammographic applications).

Preseription Use GVer- The AND/OH (Part 21 CFR-801 Subpart D) 21 6 8 8 8 8 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6

ASE DO NOT WRITE BELOW THIS LINE GONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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anggunian and a (Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices K096747 510(k) Number

Premarket Notification: