The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial 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 (not for mammography).

Device Description

The proposed System is a digital radiography diagnostic system that has the capability of obtaining two modes (static mode and dynamic modes) of radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Images may be obtained with the patient sitting, standing, or lying in the prone or supine position. It is not intended for mammographic use. The system is configurable in two options. Both are exactly the same with the exception of the option to select one of two flat panel detectors. One configuration, referred to as KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography contains a HD/FNB flat panel and the other configuration, referred to as KDR™ AU System Advanced U-Arm with Static Digital Radiography a HQ/KDR panel. The technological feature of each flat panel detector is described below.

The proposed system is a compact, floor and wall mounted radiographic system with proprietary ULTRA software and DICOM 3 connectivity.

The system consists of a combination of several components. The System's hardware consists of the 3 kev components:

A floor and wall-mounted Positioner (also referred to as a stand)
A generator
An off-the-shelf computer with proprietary software (also referred to as an acquisition workstation)

The positioner has a swivel arm that has several rotating and linear movements, and movement controls including an information screen. Mounted on the positioner are:
a) A collimator,
b) An X-ray tube
c) An Automatic Exposure Control (AEC)
d) A flat panel detector (There are 2 configurations available for the end user to select. The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography contains a HD/FNB flat panel detector capable of obtaining both static and dynamic images and the KDR™ AU System Advanced U-Arm with Static Digital Radiography, which contains the HQ/KDR flat panel detector capable of obtaining static images only.

Hardware accessories include:

A mobile patient table
Stitching stand
Weight bearing stand

Optional Hardware accessories include:

Motorized height adjustable table
3 knob collimator
Dose area product meter
Advanced weight bearing stand

The proposed system has a proprietary ULTRA software as the central interface of the system. The software for the proposed system enables users to acquire static and dynamic images.

There are two modes within the software package of the proposed system, "static mode," which may be used to generate, a single frame of radiographic images captured at a single time and "dynamic mode" (or "Dynamic Digital Radiography," abbreviated "DDR,") which generates multiple frames in a single series, presenting the physician with a diagnostic view of dynamic density and anatomic motion without using fluoroscopy or cine. The number of images acquired with the proposed system are limited to 300 compared with flouroscopy or cine, which do not limit the number of images (Note: only the configuration with the HD/FNB flat panel detector is capable of obtaining both static and dynamic images. The other configuration may only obtain static images).

The system is also capable of quickly assuming a preprogrammed position when a new exam is selected, saving time when positioning the equipment. This is referred to as "auto positioning," and made possible by the positioner and image processing software working together.

AI/ML Overview

The provided document is a 510(k) summary for the Konica Minolta Healthcare Americas KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography.

This document describes the device and its substantial equivalence to predicate devices, focusing on regulatory compliance and technical specifications rather than specific clinical performance data for AI/software components. The primary performance data discussed refers to compliance with safety and performance standards for X-ray systems, not an AI-driven diagnostic or assistive feature.

Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI component) are not present in this document. The document primarily addresses the safety and effectiveness of the X-ray system hardware and its software for image acquisition, not an AI-based diagnostic tool.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific performance metrics for an AI component. Instead, it refers to compliance with various electrical, safety, and imaging standards for the overall X-ray system.

Acceptance Criteria (Compliance with Standards)	Reported Device Performance
IEC 60601-1 version 3.1 (General requirements for basic safety and essential performance)	The System complies with the requirements.
IEC 60601-1-2, 4th edition (Electromagnetic compatibility)	The System complies with the requirements. Surrounding equipment also follows the standard. Electrical testing performed by TUV Rheinland of North America and certified as complying with each standard tested.
IEC 60601-1-3 rev 2.1 (Radiation protection in diagnostic X-ray equipment)	The System complies with the requirements.
21 CFR Part 1020:30 and 21 CFR Part 1020:31 (Standards for ionizing radiation emitting products)	The system was tested against and complies with these standards.
IEC 60601-2-54, 1.2 edition (Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy)	The System complies with the requirements.
DICOM standard	The system was also tested and complies with the DICOM standard.
User Requirement Software Specifications, Device Requirements for Performance, Packaging, Design Requirements, Human/Ergonomic Factors, Interfacing with other devices and Compatibility with the environment of the intended use	The system successfully passed all verification and validation testing, functioning as intended and expected.

2. Sample size used for the test set and the data provenance:

Not explicitly stated in the provided document. The document discusses compliance with technical standards for an X-ray system, not the performance of an AI algorithm on a specific medical image dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / not stated. This document focuses on the technical and safety performance of an X-ray imaging system, not on a machine learning model requiring expert-annotated ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / not stated. The context of this document does not involve diagnostic interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not done / not stated. The device described is an X-ray acquisition system; it does not present itself as an AI-assistive diagnostic tool for human readers in the context of this 510(k) summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable / not stated. The device is an X-ray system, which includes software for image acquisition ("proprietary ULTRA software"), but the document does not describe a standalone AI algorithm for diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / not stated. Ground truth, in the context of diagnostic AI models, is not relevant to the compliance testing of an X-ray imaging system described here.

8. The sample size for the training set:

Not applicable / not stated. The document describes an X-ray system, and there's no mention of a machine learning component requiring a training set in this context.

9. How the ground truth for the training set was established:

Not applicable / not stated. As no training set is mentioned for an AI algorithm, ground truth establishment is not relevant to the information provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

January 15, 2020

Konica Minolta Healthcare Americas, Inc. % Ms. Jan Maniscalco Director of QA/RA 2217 US Highway 70 East GARNER NC 27529

Re: K193225

Trade/Device Name: KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: November 20, 2019 Received: November 22, 2019

Dear Ms. Maniscalco:

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/cfpmn/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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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Form Approved: OMB No. 0910-0120 Expiration Date: 6/30/2020 See PRA Statement below

510(k) Number (if known) K193225

Device Name

KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography. Indications for Use (Describe)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (7/17) Page 1 of 1 EF

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510(k) SUMMARY - K193225

Manufacturer:	Konica Minolta Healthcare America, Inc2217 US Highway 70 EastGarner, NC 27529
Phone:	800-934-1034 x-1427
Facsimile:	973-523-7408
Contact Person:	Jan Maniscalco, Director of QA/RA
Date Prepared:	January 10, 2020
Establishment Registration Number:	1064396
Proprietary Name:	KDRTM AU-DDR System Advanced U-Armwith Dynamic Digital Radiography andKDRTM AU System Advanced U-Arm withStatic Digital Radiography
Classification Name:	Digital Stationary Diagnostic X-ray System
Regulation Number:	21 CFR 892.1680
Classification:	Class II, Stationary Diagnostic X-raySystem, Product Code KPR Solid State X-Ray imager (Flat Panel/Digital Imager) MQB
Predicate Device:	Viztek DR Series Digital Diagnostic DigitalX-Ray SystemsViztek, IncK082604
Reference Devices:	AERODR SYSTEM WITH P-21(K113248)(Device uses the same HQ /KDR front paneldisplay to capture static images)
	SKR3000(K172793)(Device uses the same HD/FNB front panelto capture both static and dynamic images)
	SKR3000(K182688)((Device uses same HQ/KDR and HD/FNBto capture both static and dynamic images)
	Nexus DR Digital X-ray imaging System

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(K190146) (Device uses the same generator)

Q-Rad Radiographic System with Auto-Tracker Option (K151924) (Device uses the same X-ray tubes)

Digital Diagnost C90 (K182973) (Device uses the same Collimator)

Ultra Vizion (K133139) (Device utilizes same software)

Intended Use / Indications for Use

Technological Characteristics

The proposed system is a compact, floor and wall mounted radiographic system with proprietary ULTRA software and DICOM 3 connectivity.

The system consists of a combination of several components. The System's hardware consists of the 3 kev components:

A floor and wall-mounted Positioner (also referred to as a stand)

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1. A generator
1. An off-the-shelf computer with proprietary software (also referred to as an acquisition workstation)

The positioner has a swivel arm that has several rotating and linear movements, and movement controls including an information screen. Mounted on the positioner are:

a) A collimator,
b) An X-ray tube
c) An Automatic Exposure Control (AEC)
d) A flat panel detector (There are 2 configurations available for the end user to select. The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography contains a HD/FNB flat panel detector capable of obtaining both static and dynamic images and the KDR™ AU System Advanced U-Arm with Static Digital Radiography, which contains the HQ/KDR flat panel detector capable of obtaining static images only.

Hardware accessories include:

1. A mobile patient table
1. Stitching stand
1. Weight bearing stand

Optional Hardware accessories include:

1. Motorized height adjustable table
- 1. 3 knob collimator
- 1. Dose area product meter
- 1. Advanced weight bearing stand

The proposed system has a proprietary ULTRA software as the central interface of the system. The software for the proposed system enables users to acquire static and dynamic images.

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The KDR AU-DDR system with Dynamic Digital Radiography (DDR) is a system for general radiography and differs from a Fluoroscopy system in the following ways:

-No real-time claim or functionality, no images are shown real-time for diagnostic application, low resolution images are shown during the serial exposure at a lower framerate then the acquisition for rough overview of patient positioning and to give the user feedback on rough exam progress only.

-The complete dataset of acquired images is only available after the exposure run is finished. The images then can be processed, sent to a diagnostic workstation or PACS and presented to the physician. The Ultra workstation is not intended as a diagnostic workstation.

-The exposure time is limited to a maximum time (20 sec or less if the user specifies a shorter maximum time) at 15 frames-per-sec per run, conversely fluoroscopy system are capable of almost unlimited runs, where the maximal dose is monitored during the exam, where the maximal DDR system dose is determined prior to the start of the exam.

Before exposure the user is informed the maximum allowed/set frames and frame rate, and during the exam a timer shows an indication of how much time is reminding.

-The preparation of the system between exposure sequences is relative long (5-20sec), the standby time after preparation is 5 minutes. After the 5 minutes the system will need to perform a preparation cycle before serial exposures are allowed.

Due to above operation the DDR mode is not able to perform as a fluoroscopy system. The system is not ready on-demand, what is required for fluoroscopy exams.
The DDR system uses a static exposure setting for serial imaging, which allows for an exact definition of maximum dose per exam, whereas fluoroscopy in general uses an ABS (Automatic Brightness Control), and total dose is not known before and directly controlled by the user.
Fluoroscopy imaging is used for diagnosis or quidance during the exam, while a DDR exam provides images for diagnosis only after the exam is completed and images are sent to a diagnostic review stations, not part of the KDR AU -DDR system.

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Performance Data

The proposed system was tested in its final configuration.

The System complies with the requirements of IEC 60601-1 version 3.1, regarding General requirements for basic safety and essential performance.

The System complies with the requirements of IEC 60601-1-2, 4th edition, regarding electromagnetic compatibility. Surrounding equipment also follows the standard IEC 60601-1-2. Electrical testing was performed by TUV Rheinland of North America and has been certified as complying with each standard tested.

The Test of Condition had 3 types of conditions: 1) Irradiation (Serial X-Ray Exposure) and Positioner Movement, 2) Positioner Movement and 3) Standby mode.

The System complies with the requirements of IEC 60601-1-3 rev 2.1 General requirements for basic safety and essential performance - Collateral Standard:Radiation protection in diagnostic X-ray equipment.

The system was tested against Standards No.21 CFR Part 1020:30 and standards No.21 CFR Part 1020:31

The System complies with the requirements of IEC 60601-2-54, 1.2 edition, regarding Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.

The system was also tested and complies with the DICOM standard In addition to the standards testing noted above, the system successfully passed all verification and validation testing covering user requirement software specifications, device requirements for performance, packaging, design requirements, human /ergonomic factors, interfacing with other devices and compatibility with the environment of the intended use..

In all instances, the proposed system functioned as intended and as expected.

Substantial Equivalence

The proposed System is as safe and effective as the Viztek DR Series Digital Diagnostic Digital X-Ray Systems (multiple models) K082604 and reference devices: SKR3000 (K172793); Nexus DR Digital X-ray imaging System (K190146); Q-Rad Radiographic System with Auto-Tracker Option (K151924) and Digital Diagnost C90 (K182973) and Ultra software (K133139).

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Therefore, the proposed system is also equivalent to those reference devices noted below.

	Proposed KDRTM AU-DDR SystemAdvanced U-Arm with DynamicDigital Radiography and KDRTMAU System Advanced U-Arm withStatic Digital Radiography	Predicate/ReferenceViztek DR Series DigitalDiagnostic Digital X-RaySystems (multiplemodels)K082604
Intended Use	The KDRTM AU-DDR SystemAdvanced U-Arm with DynamicDigital Radiography and KDRTMAU System Advanced U-Arm withStatic Digital Radiography isindicated for use byqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic static and serialradiographic exposures of theskull, spinal column, chest,abdomen, extremities, and otherbody parts. Applications can beperformed with the patient sitting,standing, or lying in the prone orsupine position (not formammography).	Same as predicate
Images produced	Series of static or serial digitalimages that may be viewedindividually or as a cine loop	Individual static digitalimages viewedindividually
Communication	DICOM 3.0 compliantcommunication	Same as predicate
Configuration	U arm mount	Same as predicate
PerformanceStandard	21 CFR 1020.30	Same as predicate
Generator	High FrequencyPower ratings (32-80 kW)Exposure voltage (40-150K)	High FrequencyPower ratings (50-80kW)Exposure voltage (40-150K)Note: the generator inthe proposed device isthe same as that usedin reference deviceK190146
Flat Panel Detector	See below	Provided with system
	AeroDR FPD

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	HD/FNB	KDR/HQ
Reference K	K172793	K113248
Static imaging	Yes	Yes
Dynamic imaging	Yes	No
Pixel size (um)	100	175
Spatial resolution(Lp/mm)	~5.0	~2.8
Dynamic frame rate(fps)	15	N/A
Ultra	Software	the software in theproposed device is thesame as that used inreference deviceK133139 withmodifications forserial/dynamic imaging
X-Ray table	Provided with system	Provided with systemNote: The 2 X-raytubes are the same asthat used in Referencedevice: K151924;
Collimator	Provided with system	Provided with systemNote:The collimator isthe same as that usedin Reference device:K182973;
Automatic ExposureControl, (AEC)	Provided with system	Provided with systemNote The AEC is thesame as that used inReference deviceK190146;
Electrical Safety	IEC-60601	Same as predicate

The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography system has the same intended uses and indications, and principles of operation as its predicate device. The minor technological differences between the proposed System and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the proposed System is as safe and effective as the predicate device. Thus, the proposed System is substantially equivalent.

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Conclusions - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

Data from Verification and validation data as well as external laboratory testing to applicable standards demonstrate that the proposed System is as safe and effective as the Viztek DR Series Digital Diagnostic Digital X-Ray Systems (multiple models) (K082604) and reference devices: K190146; K182973:K151924; K190146; K172793 and K113248

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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.