(53 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard radiographic system components.
No
The device is described as a "diagnostic x-ray system" used to "produce diagnostic x-ray images of human anatomy." The images are "evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan," indicating its function is for diagnosis, not therapy.
Yes
This device is explicitly described as a "diagnostic x-ray systems" intended to "produce diagnostic x-ray images of human anatomy." It is also stated that "The resultant images are evaluated by a radiologist within the diagnostic process."
No
The device description explicitly lists hardware components such as a tube support, x-ray generator, x-ray tube, radiographic wall stand, and collimator, indicating it is a physical system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that this device is a radiographic system that produces x-ray images of human anatomy. It is used for diagnostic imaging of the body itself, not for analyzing samples taken from the body.
- Intended Use: The intended use is for taking diagnostic x-rays, which is an imaging procedure, not an in vitro test.
The device is a medical imaging device, specifically a radiographic system.
N/A
Intended Use / 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.
Product codes
KPR, MQB
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.
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
adult and pediatric subjects
Intended User / Care Setting
qualified/trained physician or technician / hospitals, clinics, and medical practices
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)
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. We did collect and evaluate digital images using standardized phantoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
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
1
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
2
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
- 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) |
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.
-
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 | |
|---|---|
| ----------------------------------------------- | -- |
5
| 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 |
- 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.
6
| 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
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.
-
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.
-
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.