The OTC12D Auto System is a radiographic system used in hospitals, clinics, and medical practices. The OTC12D Auto System enables radiographic exposures of the whole body including; skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The OTC12D Auto System is not meant for mammography. The OTC12D Auto System can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The OTC12D Auto System is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Device Description

The OTC12D Auto System is a permanently-installed diagnostic x-ray system for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. It is intended to produce diagnostic x-ray images of human anatomy.

The OTC12D Auto System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography.

The OTC12D Auto System typically includes a tube support, x-ray generator, x-ray tube, radiographic table, radiographic wall stand, and collimator. Systems that include the overhead tube crane provide auto-tracking of the tube crane based on the position of the radiographic table or wall stand.

AI/ML Overview

The provided text is a 510(k) summary for the Del Medical, Inc. OTC12D Auto Radiographic System (K152767). It describes the device and claims substantial equivalence to a predicate device, the Siemens Multix Fusion (K121513).

However, this document does not describe a study that explicitly establishes acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting a specific condition) for the OTC12D Auto system derived from image analysis. Instead, the document focuses on demonstrating substantial equivalence in terms of safety and technical functionality compared to the predicate device.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of compliance with various consensus standards for safety and general functionality, rather than diagnostic accuracy. The "acceptance criteria" appear to be meeting these standards and demonstrating similar functionality to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to AAMI ES60601-1 (Basic Safety & Essential Performance)	Conforms (stated in Table 4)
Conformance to IEC 60601-1-2 (Electromagnetic Compatibility)	Conforms (stated in Table 4)
Conformance to IEC 60601-1-3 (Radiation Protection)	Conforms (stated in Table 4)
Conformance to IEC 60601-1-6 (Usability)	Conforms (stated in Table 4)
Conformance to IEC 60601-2-54 (X-Ray Equipment for Radiography)	Conforms (stated in Table 4)
Substantial equivalence in indications for use to predicate	Same (stated in Table 3)
Similar functionality for physical components (tube crane, wall stand, table, etc.)	Similar Functionality (stated in Table 3)
Safe and effective operation	Risk mitigated, instructions for use, safety features, professional operators, adheres to industry practice (Sections 7, 9)
Ability to produce diagnostic images	Intended to produce diagnostic x-ray images of human anatomy (Section 6)

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

The document does not describe a "test set" in the context of imaging performance data (e.g., a set of patient images to be evaluated for diagnostic accuracy). The testing performed is related to safety and technical standards compliance. Therefore, information about data provenance or sample size for an imaging test set is not available.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/not available because no diagnostic performance study (e.g., for detecting a specific disease) is described that would require expert-established ground truth. The device is a radiographic system, and its "performance" in this submission refers to its physical and electrical safety and functional equivalence, not its diagnostic accuracy in interpreting images.

4. Adjudication Method:

Not applicable/not available for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. This submission does not involve AI or algorithms assisting human readers. It describes a conventional X-ray system. Therefore, details about improved human reader performance with or without AI assistance are not applicable/not available.

6. Standalone (Algorithm Only) Performance Study:

No standalone algorithm performance study is mentioned. The device is an X-ray system, not an algorithm for image interpretation. Therefore, this information is not applicable/not available.

7. Type of Ground Truth Used:

Not applicable/not available because no diagnostic performance study is described. The "ground truth" implicitly referred to is compliance with engineering and safety standards, as verified through standard testing procedures.

8. Sample Size for the Training Set:

There is no mention of a "training set" in the context of machine learning or AI. The development and testing of this device relate to hardware and software engineering principles for an X-ray system. Therefore, this information is not applicable/not available.

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

Not applicable/not available for the same reasons as point 8.

Summary of the Study Discussed in the Document:

The study presented in this 510(k) summary is primarily a technical and safety conformance study, rather than a diagnostic performance study. It aims to demonstrate that the OTC12D Auto Radiographic System is substantially equivalent to a legally marketed predicate device (Siemens Multix Fusion) by:

Comparing Indications for Use: Showing they are identical.
Comparing Technological Characteristics: Highlighting similarities in components (tube crane, wall stand, table, X-ray tube, collimator, X-ray generator, operator console) and noting that differences do not affect safety or effectiveness.
Demonstrating Conformance to Consensus Standards: Providing a table of FDA-recognized consensus standards (AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54) for electromagnetic compatibility, mechanical and electrical safety, radiation protection, and usability. The document states that testing for verification and validation of the device was found acceptable to support claims of substantial equivalence.
Risk Management: Stating that identified risks (EMC, mechanical, electrical hazards) were mitigated.

The "study" asserts that "Clinical testing is not required for a determination of substantial equivalence" for this type of device, which further clarifies why diagnostic performance parameters are not provided.

Summary

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

December 14, 2015

Del Medical, Inc. % Daniel Kamm, P.E. Kamm and Associates 8870 Ravello Court NAPLES FL 34114

Re: K152767

Trade/Device Name: OTC12D Auto Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: November 23, 2015 Received: November 30, 2015

Dear Mr. 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. 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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert 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) K15 /

Device Name OTC12D Auto Radiographic System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: Del Medical, Inc. OTC12D Auto X-Ray System K152767

Company:	Del Medical, Inc.241 Covington Dr.Bloomingdale, IL 60108
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December 8, 2015 Date Prepared:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

1. General Information:

Establishment/Manufacturer/Location of Manufacturing Site: Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 Establishment Registration Number: 1418964

2. Contact Person:

John Hartzell Regulatory/Compliance Engineer c/o Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 Phone: 847-288-7021

3. Device Name and Classification

Trade Name:	OTC12D Auto
Regulation Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	90 KPR

4. Legally Marketed Predicate Device

Trade Name:	Multix Fusion
510(k) #:	K121513
Clearance Date:	August 10, 2012
Regulation Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	90 KPR

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5. Indications for Use

The OTC12D Auto System is a radiographic system used in hospitals, clinics, and medical practices. The OTC12D Auto System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The OTC12D Auto System is not meant for mammography. The OTC12D Auto System can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The OTC12D Auto System is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

6. Device Description

Below are the specific components in various configurations to form a radiographic system used for general purpose radiographic imaging (see Table 1). Note that the customer supplies their own digital xray panel. We do not supply it.

Table 1. Components used in Del Medical, Inc. OTC12D Auto System
System Component Type	Manufacturer	Model Number(s)
Tube Support, Tube Crane	Del Medical Inc.	OTC-12D Auto
OR one of the Tube Stands listed below.
Tube Support, Tube Stand	Del Medical Inc.	DFMTS
Tube Support, Tube Stand	Del Medical Inc.	DFMTS-PS
Tube Support, Tube Stand	Del Medical Inc.	FMTS
Tube Support, Tube Stand	Del Medical Inc.	FWFC
Generator
X-ray Generator	CPI	CMP200
OR one of the alternate generators shown below.
X-ray Generator, with User Interface	CPI	CMP200 DR
X-ray Generator, with User Interface	CPI	Indico 100
X-ray Generator, with User Interface	Siemens	Series Polydoros RF Rad 80, Model No. 10307360

Table 1, Components used in Del Medical Inc. OTC12D Auto System

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System Component Type	Manufacturer	Model Number(s)
X-ray tube
X-ray Tube	Toshiba	E7254FX, E7255FX, E7252FX, E7239FX,E7242FX
OR one of the x-ray tubes shown below.
X-ray Tube	Varian	RAD14, RAD60, RAD92
X-ray Tube	Siemens	Series SV 150/40/80C-100, Model No.4802349
Table
Radiographic Table, Non-Elevating	Del Medical Inc.	RT-100
OR one of the tables shown below.
Radiographic Table,Elevating	Del Medical Inc.	EV-650
Radiographic Table,Elevating	Del Medical Inc.	EV-800
Available Wall Stands
Radiographic Wall Stand	Del Medical Inc.	3546E (VS100)
Radiographic Wall Stand	Del Medical Inc.	VS200
Radiographic Wall Stand	Del Medical Inc.	VS300
Available Collimators
Collimator, Manual	Siemens	Series ML01 II, Model 10092611
Collimator, Automatic	Siemens	Series AL02 II eL, Model No. 10092614
Auto Collimator	Ralco	Ralco R221

The reason these models should be cleared under this 510(k) umbrella is that all of these components have been previously evaluated for safety and effectiveness via these main methods:

1. Previous clearances via the 510(k) route. (i.e. combinations.)
The fact that the components (generators, tube heads, and collimators) themselves do not require 2. 510(k) notification because they are either Class I or are otherwise exempt.
1. The fact that they carry NRTL stickers meaning they all have been safety tested.
1. The fact that they have previous product reports showing compliance with the CFR Radiation Safety Standards.
1. The fact that our trained test technicians verify proper operation of every system installed in the field.

6. Substantial Equivalence

The OTC12D Auto radiographic x-ray system is substantially equivalent to the commercially available Siemens Multix Fusion (K121513) radiographic x-ray system with similar indications for use. The Multix Fusion was described in premarket notification K121513 which received FDA Clearance on August 10, 2012 (See Table 2 below).

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Table 2: Predicate Device
Predicate DeviceName &Manufacturer	510(k) Number	Clearance Date	Comparable Properties
Multix Fusion,Siemens AG/SiemensHealthcare GmbH	K121513	August 10,2012	Tube crane/Tube standWall stand, Table, X-ray tube,CollimatorX-ray Generator, Operatorconsole

The functional differences are between the OTC12D Auto and the Siemens Multix Fusion are shown below in Table 3.

Table 3: Subject and Predicate Device Comparable Properties

ComparableProperties	Subject Device: OTC12D Auto	Predicate Device: SiemensMultix Fusion K12113	ComparisonResults
Indications foruse	The OTC12D Auto System is aradiographic system used inhospitals, clinics, and medicalpractices. The OTC12D AutoSystem enables radiographicexposures of the whole bodyincluding: skull, chest, abdomen,and extremities and may be used onpediatric, adult, and bariatricpatients. It can also be used forintravenous, small interventions(like biopsy, punctures, etc.) andemergency (trauma, critically ill)applications. Exposures may betaken with the patient sitting,standing, or in the prone position.The OTC12D Auto System is notmeant for mammography. TheOTC12D Auto System can use amobile (wired) or portable(wireless) digital detector (notprovided with system) forgenerating diagnostic images byconverting x-rays into electronicsignals. The OTC12D Auto Systemis also designed to be used withconventional film/screen orComputed Radiography (CR)cassettes.	The Multix Fusion system is aradiographic system used inhospitals, clinics, and medicalpractices. Multix Fusion enablesradiographic exposures of thewhole body including: skull, chest,abdomen, and extremities and maybe used on pediatric, adult, andbariatric patients. It can also beused for intravenous, smallinterventions (like biopsy,punctures, etc.) and emergency(trauma, critically ill) applications.Exposures may be taken with thepatient sitting, standing, or in theprone position. The Multix Fusionsystem is not meant formammography.The Multix Fusion uses a mobile(wired) or portable (wireless)digital detector for generatingdiagnostic images by converting x-rays into electronic signals. TheMultix Fusion is also designed tobe used with conventionalfilm/screen or ComputedRadiography (CR) cassettes.	Same
Tubecrane/Tubestand	Overhead tube crane withmanual or automated x-ray tubeassembly movement; tube standwith manual x-ray tube assemblymovement.	Overhead tube crane withmanual or automated x-ray tubeassembly movement.	SimilarFunctionality
ComparableProperties	Subject Device: OTC12D Auto	Predicate Device: SiemensMultix Fusion K12113	ComparisonResults
Wall stand	Manual vertical movable wallstand, non-tiltable tray.	Manual vertical movable wallstand, tiltable tray.	SimilarFunctionality
Table	Free-floating and height-adjustable, maximum patientweight 800 lbs., working tableheight 22 inch to 34 inch; free-floating, maximum patientweight 700 lbs., working tableheight 33 inch.	Free-floating and height-adjustable, maximum patientweight 660 lbs., working tableheight 20-5/16 inch to 37-5/8inch.	Same orSimilarFunctionality
X-ray tube	125 kV maximum operatingvoltage, 1.5 mm and 0.6 mmfocal spots;125 kV maximum operatingvoltage, 2.0 mm and 1.0 mmfocal spots;150 kV maximum operatingvoltage, 1.0 mm and 0.6 mmfocal spots;150 kV maximum operatingvoltage, 1.2 mm and 0.6 mmfocal spots.	150 kV maximum operatingvoltage, 1 mm and 0.6 mmfocal spots.	SimilarFunctionality
Collimator	ACSS collimator (AutomaticCassette Size Sensing); Manualformat collimation.	ACSS collimator (AutomaticCassette Size Sensing).	SimilarFunctionality
X-rayGenerator	Rated power: 100 kW, 80 kW,65 kW, 50 kW, 40 kW, 32 kW.	Rated power: 80 kW, 65 kW,55 kW.	SimilarFunctionality
Wirelessdetector	Supports various sizes ofwireless detectors (not providedwith system):7" x 9.5"; 9.5" x 9.5";10" x 12"; 14" x 17"12" x 12"; 10" x 8"14" x 14"; 17" x 17"7" x 17"	14" x 17"	SimilarFunctionality
Fixeddetector	Supports various sizes of fixeddetectors (not provided withsystem):7" x 9.5"; 9.5" x 9.5"10" x 12"; 14" x 17"12" x 12"; 10" x 8"14" x 14"; 17" x 17"7" x 17"	17" x 17"	SimilarFunctionality
Conventionalfilm/screensystems orCR cassettes	Film/Screen or CR Cassettes.	Film/Screen or CR Cassettes.	SimilarFunctionality
Operatorconsole	GUI-based	GUI-based	SimilarFunctionality

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7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device

The OTC12D Auto System uses a similar radiographic x-ray system as the predicate device. The differences in the subject device, such as the x-ray generator, radiographic table, wall stand, tube crane, collimator, and x-ray tube, do not affect the safety or effectiveness of the device. The OTC12D Auto System can use a wireless or fixed flat panel detector (not provided with system) similar to the predicate device, and the differences do not adversely affect the safety or effectiveness of the radiographic x-ray system.

The properties of the subject device presented in the comparison table above (see Table 3) and described throughout this submission do not differ significantly from the legally marketed predicate device with regards to fundamental scientific technology, nor do they reflect a significant change in the indications for use. The differences between the subject device and the legally marketed predicate device have been assessed using Risk Management and through third-party evaluation using FDA-recognized consensus standards. The results of these efforts demonstrate that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness than the predicate.

8. Performance Testing

Del Medical claims conformance to a signed statement of performance standards. This submission contains performance data and test results to demonstrate conformance with special controls for medical devices containing software for a moderate level of concern per the FDA document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

EMC, mechanical safety, and electrical safety were evaluated according to various FDA-recognized consensus standards (see Table 4 below). In conclusion, the identified risk of EMC, mechanical, and electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. Clinical testing is not required for a determination of substantial equivalence.

RecognitionNumber	ProductArea	StandardReferenceNumber	Standard Title and Edition
19-5	General	AAMIES60601-1	AAMI / ANSI ES60601-1:2005/(R)2012 AndC1:2009/(R)2012 And, A2:2010/(R)2012 (ConsolidatedText) Medical Electrical Equipment -- Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, Mod)
19-1	General	IEC60601-1-2	IEC 60601-1-2 Edition 3: 2007-03, Medical ElectricalEquipment - Part 1-2: General Requirements For BasicSafety And Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements AndTests
12-210	Radiology	IEC60601-1-3	IEC 60601-1-3 Edition 2.0 2008-01, Medical ElectricalEquipment - Part 1-3: General Requirements For BasicSafety And Essential Performance - Collateral Standard:Radiation Protection In Diagnostic X-Ray Equipment

Table 4: Conformance to Consensus Standards

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RecognitionNumber	ProductArea	StandardReferenceNumber	Standard Title and Edition
5-89	General	IEC60601-1-6	IEC 60601-1-6 Edition 3.1 2013-10, Medical ElectricalEquipment - Part 1-6: General Requirements For BasicSafety And Essential Performance - Collateral Standard:Usability
12-274	Radiology	IEC60601-2-54	IEC 60601-2-54 Edition 1.0 2009-06, Medical ElectricalEquipment - Part 2-54: Particular Requirements For TheBasic Safety And Essential Performance Of X-RayEquipment For Radiography And Radioscopy[Including: Technical Corrigendum 1 (2010), TechnicalCorrigendum 2 (2011)]

9. General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features, including an emergency stop button, are incorporated into the system design. In addition, operation of the OTC12D Auto System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

Furthermore, the intended operators of the OTC12D Auto System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

10. Conclusion as to Substantial Equivalence

The OTC12D Auto System is intended for the same use as the Multix Fusion. It uses components similar to those cleared for the Multix Fusion (e.g. tube crane/tube stand, wall stand, table, x-ray tube, collimator, x-ray generator, operator console). It is Del Medical, Inc.'s opinion that the OTC12D Auto System is substantially equivalent to the cleared predicate device, the Multix Fusion.

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.