← Product Code [KPR](/productcode/KPR) · K173823
# Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System (K173823)
_Summit Industries, LLC · KPR · Feb 9, 2018 · Radiology · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K173823
## Device Facts
- **Applicant:** Summit Industries, LLC
- **Product Code:** [KPR](/productcode/KPR.md)
- **Decision Date:** Feb 9, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1680
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Indications for Use
These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
## Device Story
Amrad Medical Digital Radiography Systems (AAU, AAU Plus, DFMT, FMT) are permanently-installed diagnostic x-ray systems for general purpose imaging in hospitals and clinics. Systems consist of an x-ray generator, tube, collimator, tube support (floor-mounted or U-arm), and radiographic table/wall stand. Input is ionizing radiation passed through human anatomy; output is digital x-ray images processed via an integrated FDA-cleared digital imaging system (Thales/CMT ArtPix Mobile EZ2GO). Operated by physicians or technicians; images are reviewed by radiologists to inform treatment plans. Benefits include diagnostic visualization of whole-body anatomy for adult, pediatric, and bariatric patients.
## Clinical Evidence
Bench testing only. No clinical study required as digital x-ray panels and software were previously FDA-cleared. Performance evaluated using standardized phantoms to verify image quality.
## Technological Characteristics
Stationary X-Ray System (21 CFR 892.1680). Components: High-frequency X-ray generators (40-80kW), Toshiba X-ray tubes, Ralco collimators, Sedecal/Summit mechanical supports. Digital imaging via Thales/CMT Pixium Portable 3543 EZ/2430 EZ wireless detectors. Connectivity: Tablet PC with Windows OS. Safety: UL/ETL certified. Sterilization: N/A (non-invasive).
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- Amrad Medical OTS Digital Radiography System ([K153119](/device/K153119.md))
- Amrad Medical DFMTS Digital Radiography System ([K153119](/device/K153119.md))
- Amrad Medical FRS Digital Radiography System ([K153119](/device/K153119.md))
## Reference Devices
- THALES/ CMT Medical Technologies Ltd. ArtPix Mobile EZ2GO ([K162224](/device/K162224.md))
## Submission Summary (Full Text)
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February 9, 2018
Summit Industries LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114
Re: K173823
Trade/Device Name: Amrad Medical AAU Digital Radiography System: Amrad Medical AAU Plus Digital Radiography System: Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MQB Dated: December 13, 2017 Received: December 18, 2017
Dear Daniel 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
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801 and Part 809: 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
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) K173823
#### Device Name
System #1: Amrad Medical AAU Digital Radiography System; System #2: Amrad Medical AAU Plus Digital Radiography System System #3: Amrad Medical DFMT Digital Radiography System: #4: Amrad Medical FMT Digital Radiography System
### Indications for Use (Describe)
These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
|
|
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# 510(k) Summary: Amrad Medical Digital Radiography Systems K173823
| Company: | Summit Industries, LLC 7555 North Caldwell Avenue, Niles, Illinois 60714 USA Phone 773-353-4024 Fax 773-588-3424 Establishment Registration Number: 145050 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 13, 2017 |
| Contact Person: | Tom Boon, President |
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
### 1. Device Name and Classification
| Trade Names: | System #1: Amrad Medical AAU Digital Radiography System System #2: Amrad Medical AAU Plus Digital Radiography System System #3: Amrad Medical DFMT Digital Radiography System System #4: Amrad Medical FMT Digital Radiography System |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
## 2. Legally Marketed Predicate Device
| Trade Names: | System #1: Amrad Medical OTS Digital Radiography System System #2: Amrad Medical DFMTS Digital Radiography System System #3: Amrad Medical FRS Digital Radiography System |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) #: | K153119 |
| Regulation Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
3. Reference Device (Imaging System) The Amrad Systems employ software and digital panels cleared by FDA: THALES/ CMT Medical Technologies Ltd. ArtPix Mobile EZ2GO using Pixium Portable 3543 EZ and 2430 EZ Wireless Detectors
| 510(k) #: | K162224 |
|----------------------------|--------------------------------------------------------------|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Subsequent Product Code: | MQB - solid-state X-Ray imager (flat panel / digital imager) |
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4. Indications for Use: These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.
5. Device Description: The Amrad Systems are permanently-installed diagnostic x-ray systems for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. They are intended to produce diagnostic x-ray images of human anatomy. The Amrad Systems enable 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 Amrad Systems typically include a tube support, x-ray generator, x-ray tube, radiographic wall stand, and collimator. An FDA cleared digital imaging system is included. Below are the specific components in various configurations to form a radiographic system used for general purpose radiographic imaging (see Table 1).
| Component Category | Component Description | Component Model. | Mfr./ Location | Amrad Medical AAU System | Amrad Medical AAU Plus System | Amrad Medical DFMT System | Amrad Medical FMT System |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------|-----------------------------------|-------------------------------------------|------------------------------------|-----------------------------------|
| Tubestand | Floor Rail mounted Tube Support | J700 / J700D | Summit USA | | | X | X |
| Wallstand | Tilting, Rotational Vertical Wallstand (Floor to wall mounted) with Receptor for Bucky or grid cabinet includes cassette tray, X- ray Grid & may include 1 optional AEC radiation detector | "Millennium" TWBS-TILT | Sedecal Spain | | | X | X |
| | Wallstand with Bucky or grid cabinet, includes cassette tray, X-ray grid & may include 1 optional AEC radiation detector (for floor to wall mounting) | J1000 | Summit USA | | | X | X |
| Combination Tubestand/ Cassette Holder ("C-Arm") | Floor Mounted to wall mounted U-Arm with motorized vertical, rotational and SID movement with receptor for Bucky or grid cabinet, includes cassette tray, removable X-ray grid & may include 1 optional AEC radiation detector | X Plus LP PLUS | Sedecal Spain | X | X | | |
| Table 1. Components used Note: X = Included | |
|-----------------------------------------------|--|
|-----------------------------------------------|--|
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| Component Category | Component Description | Component Model. | Mfr ,/ Location | Amrad Medical AAU System | Amrad Medical AAU Plus System | Amrad Medical DFMT System | Amrad Medical FMT System |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------|-----------------------------------|-------------------------------------------|------------------------------------|-----------------------------------|
| Radiographic Table | Elevating 4-way Float Top Table And Non- elevating 4 way Float Top Table Includes Reciprocating Bucky or Grid Cabinet, cassette tray, X-Ray Grid & may include optional AEC radiation detector | S222 - Elevating S223 - Non-elevating | Summit USA | | | X | X |
| Radiographic Table | Mobile Table | ST-1000 | SYFM Korea | X | X | | |
| | X-ray Generator, 80kW, HF, 150kV, (AEC optional) | SHFR 800 | Sedecal, Spain | | | | |
| X-ray Generator | X-ray Generator, 65kW, HF, 150kV, (AEC optional) | SHFR 600 | Sedecal, Spain | Select one | Select one | Select one | Select one |
| | X-ray Generator, 50kW, HF, 150kV, (AEC optional) | SHFR 500 | Sedecal, Spain | | | | |
| | X-ray Generator, 40kW, HF, 150kV, (AEC optional) | SHFR 400 | Sedecal, Spain | | | | |
| X-ray Beam Limiting Device | Manual Collimator with LED light source, laser alignment lights & tape measure | R 221 or R225 | Ralco Italy | X | X | X | X |
| Digital Imaging System | Complete Digital Imaging System including Tablet PC (w/ Window OS, monitor, keyboard & mouse), THALES/ CMT Medical Technologies Ltd. K162224 ArtPix Mobile EZ2GO using Pixium Portable 3543 EZ and 2430 EZ Wireless Detectors | Pixium Portable 3543 EZ and 2430 EZ Wireless Detectors | Thales/CMT Medical, France/ Israel | X | X | X | X |
| X-ray Tube | Toshiba X-ray Tubes, various models | E7242x. E7252X. E7254x. E7255X. E7869X. | Toshiba Electron Tubes & Devices Co. Ltd. | Select one | Select one | Select one | Select one |
6. Substantial Equivalence: The Amrad Medical Systems (4 models) are substantially equivalent to the commercially available Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 radiographic xray system with identical indications for use. The similarities and differences are shown in Table 2, below.
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| Comparable Properties | Subject Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 | Amrad Medical AAU, AAU Plus, DFMT, or FMT Digital Radiography Systems K173823 | Comparison Results |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Indications for use | These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use. | These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use. | Identical |
| Tube crane/Tube stand | Overhead tube crane: OTS | No Overhead tube crane. Only U- Arm, Floor Stand, or Wall/Floor Stand available | Similar Functionality |
| Wall stand | Manual or Motorized | Manual or Motorized | SAME |
| Table | Elevating 4-way Float Top Table includes reciprocating bucky, cassette tray, X-ray grid & may include optional AEC measuring detector (for use with OTS & DFMTS Tubestands only) or: Mobile Table (for use with FRS System only) | Elevating 4-way Float Top Table includes reciprocating bucky, cassette tray, X-ray grid & may include optional AEC measuring detector (for use with DFMT & FMT Tubestands only) or: Mobile Table (for use with AAU and AAU Plus) | Same or Similar Functionality |
| X-ray tube | 150 kVp 0.6/1.2mm focal spots | 150 kVp 0.6/1.2mm focal spots | Similar Functionality |
| Collimator | Collimare | Ralco R221 or R225 | Similar Functionality |
| X-ray Generator | CPI Models: 40, 50, 65, or 80 kW | Sedecal Models: 40, 50, 65, or 80 kW | Identical Functionality |
| Wireless detector | Not applicable | Yes, Cleared Wi-Fi | Greater convenience |
| Fixed detector | Uses FDA cleared detectors and software: VARIAN PaxScan 4343R and 4336R panels and software cleared in K093066 as well as in K130318. | Uses FDA cleared detectors and software: THALES/ CMT Medical Technologies Ltd. K162224 ArtPix Mobile EZ2GO using Pixium Portable 3543 EZ and 2430 EZ Wireless Detectors | Similar Functionality |
| Conventional film/screen systems or CR cassettes | Comes with FDA cleared digital x-ray panels. Conventional film and CR cassettes can still be used. | Comes with FDA cleared digital x- ray panels. Conventional film and CR cassettes can still be used. | Similar Functionality |
| Operator console | Provided | Same | Similar Functionality |
| Comparable Properties | Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 | Amrad Medical AAU, AAU Plus, DFMT, or FMT Digital Radiography Systems K173823 | Comparison Results |
| Photos | Image: Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 | Image: Amrad Medical AAU, AAU Plus, DFMT, or FMT Digital Radiography Systems K173823 | Similar Functionality Customer preference is the only difference. |
| Power Source | AC LINE | SAME | Same. |
# Table 2: Subject and Predicate Device Comparable Properties
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7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: As can be seen from the table above, the devices are functionally identical in that they can perform the same kinds of x-ray imaging, but they are different in the mechanical aspects. For example the tube head/collimator combination is celling mounted in the predicate whereas the same components are floor mounted in the modified system. In the predicate system, Varian digital panels are employed whereas in the modified system Thales/CMT digital panels are employed. The panels were all previously cleared by FDA in both systems. In all important respects the Amrad Systems are functionally identical and technologically similar in design and composition to the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119.
8. Performance Testing. EMC, mechanical safety, and electrical safety were evaluated according to various FDA-recognized consensus standards. 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 because the imaging components supplied have already received FDA clearance. Furthermore, the intended operators of the Amrad Medical AAU, AAU Plus, DFMT, or FMT Digital Radiography Systems are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Summit Industries LLC adheres to recognized and established industry practice, and all equipment is subject to final performance testing. All components bear the UL or ETL certification labels.
9. Clinical Evaluation: Since the digital x-ray panels and software had previously received FDA clearance, a clinical study as required by the FDA guidance document was not required. We did collect and evaluate digital images using standardized phantoms.
## 10. Conclusion as to Substantial Equivalence
The Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems are intended for the same use as the Amrad predicate. It uses components similar to those cleared for the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119 (e.g. tube stand, wall stand, table, x-ray tube, collimator, x-ray generator, operator console). Summit Industries LC's opinion that the proposed systems are substantially equivalent to the cleared predicate device, the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems K153119.
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**Source:** [https://fda-staging.innolitics.com/device/K173823](https://fda-staging.innolitics.com/device/K173823)
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