(81 days)
Not Found
No
The document describes a standard radiographic system with auto-tracking based on physical position, not AI/ML. There are no mentions of AI, ML, deep learning, or image processing capabilities that would suggest AI/ML is used for image analysis or other functions.
No
The device is described as a radiographic system used for generating diagnostic images, and its components and intended use are focused on imaging, not on treating conditions or diseases.
Yes
The device description explicitly states, "The OTC12D Auto System is a permanently-installed diagnostic x-ray system for general purpose radiographic imaging..." and "It is intended to produce diagnostic x-ray images of human anatomy." The intended use also mentions "generating diagnostic images." These statements confirm its diagnostic purpose.
No
The device description explicitly lists hardware components such as a tube support, x-ray generator, x-ray tube, radiographic table, radiographic wall stand, and collimator, indicating it is a physical system, not software-only.
Based on the provided information, the OTC12D Auto System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- OTC12D Auto System Function: The OTC12D Auto System is a radiographic system that uses X-rays to create images of the internal structures of the human body directly, without requiring the collection and analysis of biological specimens.
The description clearly states its purpose is for "radiographic exposures of the whole body" and "to produce diagnostic x-ray images of human anatomy." This aligns with the definition of a medical imaging device, not an IVD.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
KPR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
whole body including; skull, chest, abdomen, and extremities
Indicated Patient Age Range
pediatric, adult, and bariatric patients
Intended User / Care Setting
hospitals, clinics, and medical practices. The intended operators of the OTC12D Auto System are health care professionals familiar with and responsible for the x-ray examinations being performed.
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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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.
1
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
2
Indications for Use
510(k) Number (if known) K15 /
Device Name OTC12D Auto Radiographic System
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary: Del Medical, Inc. OTC12D Auto X-Ray System K152767
| Company: | Del Medical, Inc.
241 Covington Dr.
Bloomingdale, IL 60108 |
| ---------- | ------------------------------------------------------------------ |
|---|
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 |
4
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
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.
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
5
| 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:
-
- 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.
-
- The fact that they carry NRTL stickers meaning they all have been safety tested.
-
- The fact that they have previous product reports showing compliance with the CFR Radiation Safety Standards.
-
- 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 Device | |||
| Name & | |||
| Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
| Multix Fusion, | |||
| Siemens AG/Siemens | |||
| Healthcare GmbH | K121513 | August 10, | |
| 2012 | Tube crane/Tube stand | ||
| Wall stand, Table, X-ray tube, | |||
| Collimator | |||
| X-ray Generator, Operator | |||
| console |
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
| Comparable
Properties | Subject Device: OTC12D Auto | Predicate Device: Siemens
Multix Fusion K12113 | Comparison
Results |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 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, 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. | The Multix Fusion system is a
radiographic system used in
hospitals, clinics, and medical
practices. Multix Fusion 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 Multix Fusion
system is not meant for
mammography.
The Multix Fusion uses a mobile
(wired) or portable (wireless)
digital detector for generating
diagnostic images by converting x-
rays into electronic signals. The
Multix Fusion is also designed to
be used with conventional
film/screen or Computed
Radiography (CR) cassettes. | Same |
| Tube
crane/Tube
stand | Overhead tube crane with
manual or automated x-ray tube
assembly movement; tube stand
with manual x-ray tube assembly
movement. | Overhead tube crane with
manual or automated x-ray tube
assembly movement. | Similar
Functionality |
| Comparable
Properties | Subject Device: OTC12D Auto | Predicate Device: Siemens
Multix Fusion K12113 | Comparison
Results |
| Wall stand | Manual vertical movable wall
stand, non-tiltable tray. | Manual vertical movable wall
stand, tiltable tray. | Similar
Functionality |
| Table | Free-floating and height-
adjustable, maximum patient
weight 800 lbs., working table
height 22 inch to 34 inch; free-
floating, maximum patient
weight 700 lbs., working table
height 33 inch. | Free-floating and height-
adjustable, maximum patient
weight 660 lbs., working table
height 20-5/16 inch to 37-5/8
inch. | Same or
Similar
Functionality |
| X-ray tube | 125 kV maximum operating
voltage, 1.5 mm and 0.6 mm
focal spots;
125 kV maximum operating
voltage, 2.0 mm and 1.0 mm
focal spots;
150 kV maximum operating
voltage, 1.0 mm and 0.6 mm
focal spots;
150 kV maximum operating
voltage, 1.2 mm and 0.6 mm
focal spots. | 150 kV maximum operating
voltage, 1 mm and 0.6 mm
focal spots. | Similar
Functionality |
| Collimator | ACSS collimator (Automatic
Cassette Size Sensing); Manual
format collimation. | ACSS collimator (Automatic
Cassette Size Sensing). | Similar
Functionality |
| X-ray
Generator | Rated power: 100 kW, 80 kW,
65 kW, 50 kW, 40 kW, 32 kW. | Rated power: 80 kW, 65 kW,
55 kW. | Similar
Functionality |
| Wireless
detector | Supports various sizes of
wireless detectors (not provided
with 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" | Similar
Functionality |
| Fixed
detector | Supports various sizes of fixed
detectors (not provided with
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" | 17" x 17" | Similar
Functionality |
| Conventional
film/screen
systems or
CR cassettes | Film/Screen or CR Cassettes. | Film/Screen or CR Cassettes. | Similar
Functionality |
| Operator
console | GUI-based | GUI-based | Similar
Functionality |
7
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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.
| Recognition
Number | Product
Area | Standard
Reference
Number | Standard Title and Edition |
|-----------------------|-----------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-5 | General | AAMI
ES60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 And
C1:2009/(R)2012 And, A2:2010/(R)2012 (Consolidated
Text) Medical Electrical Equipment -- Part 1: General
Requirements For Basic Safety And Essential
Performance (IEC 60601-1:2005, Mod) |
| 19-1 | General | IEC
60601-1-2 | IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical
Equipment - Part 1-2: General Requirements For Basic
Safety And Essential Performance - Collateral Standard:
Electromagnetic Compatibility - Requirements And
Tests |
| 12-210 | Radiology | IEC
60601-1-3 | IEC 60601-1-3 Edition 2.0 2008-01, Medical Electrical
Equipment - Part 1-3: General Requirements For Basic
Safety And Essential Performance - Collateral Standard:
Radiation Protection In Diagnostic X-Ray Equipment |
Table 4: Conformance to Consensus Standards
9
| Recognition
Number | Product
Area | Standard
Reference
Number | Standard Title and Edition |
|-----------------------|-----------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5-89 | General | IEC
60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical
Equipment - Part 1-6: General Requirements For Basic
Safety And Essential Performance - Collateral Standard:
Usability |
| 12-274 | Radiology | IEC
60601-2-54 | IEC 60601-2-54 Edition 1.0 2009-06, Medical Electrical
Equipment - Part 2-54: Particular Requirements For The
Basic Safety And Essential Performance Of X-Ray
Equipment For Radiography And Radioscopy
[Including: Technical Corrigendum 1 (2010), Technical
Corrigendum 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.