These radiographic systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Description

Proteus Radiographic System, Models XR/f ST and XR/f ET; MULTIRAD and MULTIRAD NET. These radiographic systems are designed for general radiography in hospitals, clinics, radiology imaging centers and medical practices. It is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Patients may be physically abled, disabled, immobilized or in state of a shock. The Radiographic Systems are not intended for mammography applications. If children are to be examined, they should always be accompanied by an adult.

Radiographic System Proteus XR/f has been interfaced with the Digital Imaging System of Konica Minolta Inc consisting of the image receptor and application for image acquisition (control console & image processing controller).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Proteus XR/f, Models ST and ET, Multirad, and Multirad NET Radiographic Systems:

Acceptance Criteria and Device Performance:

The document describes the device as being "substantially equivalent" to a legally marketed predicate device (K090279: Sedecal "Millennium Plus Digital Diagnostic X-Ray System") and references a reference device (K182688: Konica Minolta Wireless Detector SKR3000) without modification. The performance comparison is primarily qualitative, focusing on similar specifications and compliance with standards rather than explicit quantitative acceptance criteria with reported numerical performance.

Here's a table summarizing the implicit acceptance criteria based on the comparison to the predicate devices and the reported device characteristics:

Acceptance Criteria (Implied from Predicate/Reference Device Comparison & Standards)	Reported Device Performance (Proteus XR/f)
Indications for Use: Same as predicate device (diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts, for adult and pediatric subjects, sitting, standing, prone, or supine positions).	Same (Wording allows for both digital and traditional versions, essentially equivalent to the predicate)
Digital Receptor Panel/Panel Sizes: Performance comparable to predicate's Canon models.	Konica Minolta Wireless Detector SKR3000, K182688 (Reference device, without modification). Specific models: AeroDR 2 1417S, AeroDR 3 1417HD, AeroDR 3 1012HQ, AeroDR 3 1717HD.
Panel Properties: Comparable to predicate's $160 \mu m$, 2208 × 2688, 14 x 17 panel size, 12 bit.	$100 \mu m / 200 \mu m$, 1,994 x 2,430, 14 x 17 and 17 x 17 panel sizes, 16 bit. (Higher resolution/bit depth reported, indicating equivalent or better.)
Typical MTF/DQE: Performance comparable to predicate's 0.70 @ 1 lp/mm (MTF) and 0.30 @ 1 lp/mm (DQE).	MTF: 0.53 at 1 cycle/mm, DQE: 0.51 at 1 cycle/mm. Similar performance (explicitly stated).
Tube Mount: Same as predicate (Wall/Floor Suspension).	SAME
Image Acquisition Software: Comparable to Canon control software CXDI-NE.	Konica Minolta CS-7 provided with panel (provided with the reference panel).
Panel Interface: Ethernet or Wi-Fi wireless.	SAME or Wi-Fi wireless (Supports both, similar to predicate's Ethernet and extended with Wi-Fi).
Compliance with US Performance Standards: 21 CFR 1020.30 and 21 CFR 1020.31.	SAME (Explicitly stated to meet these standards).
X-ray Generator Output Power: Comparable to predicate's SHF Family: 32, 40 kW, 64 kW, 80 kW.	SHFR Family: 50 KW, 65 KW, 80 KW. SIMILAR RANGE OF OUTPUT POWER (explicitly stated).
kVp Range & Accuracy: Comparable to predicate's 40-125/150 kV, ±(3% + 1 kVp).	40-150 kV, ±(3% + 1 kVp). (Similar range and accuracy, extended to 150 kV).
mA Range & Accuracy: Comparable to predicate's 10-800 mA, ±(4% + 1 mA).	10-800 mA, ±(4% + 1 mA). (Similar range and accuracy).
mAs Range & Accuracy: Comparable to predicate's 0.1-500/640 mAs, ±(10% + 0.2 mAs).	0.1-650 mAs, ±(10% + 0.2 mAs). (Similar range and accuracy, extended to 650 mAs).
Collimator: Functionally similar to Ralco R 302/A DHHS.	Ralco R 225 DHHS (Manual Collimator) (updated version of collimator).
Power Source: Mains operated.	SAME
Safety and Effectiveness: As safe and effective as predicate devices.	Confirmed through bench testing and compliance with various international standards (IEC 60601 series).
Firmware Validation: Complies with FDA guidance.	Validated according to FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005."
Cybersecurity: Complies with FDA guidance.	Observed recommendations in FDA Guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014." Covered by the digital panel (K182688).
Pediatric Information: Labeling includes pediatric information.	Labeling developed and information provided in accordance with FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications, November 2017" and reference to Image Gently website.
Wireless Technology: Complies with FDA guidance (if applicable).	Consulted FDA Guidance: "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, AUGUST 2013" and incorporated recommendations into labeling (pertaining to K182688).

Study Information:

Sample size used for the test set and the data provenance:
- The document states: "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance."
- Therefore, there is no explicit test set of patient images or data described for the Proteus XR/f system itself. The substantial equivalence relies on non-clinical (bench) testing and the prior clearance of its components (particularly the digital x-ray detector panel).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth establishment for the Proteus XR/f was conducted. The clearance is based on substantial equivalence to predicate devices and component (digital x-ray receptor panel) clearances.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set was conducted.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was mentioned or performed. This device is an X-ray system, not an AI-powered diagnostic tool, so such a study would not be relevant for its primary clearance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is an X-ray imaging system, not an AI algorithm. Its performance is related to image quality and system functionality, not diagnostic algorithmic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the X-ray system itself, the "ground truth" for its performance is assessed through bench testing against established engineering and safety standards (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31) and comparison of technical specifications (kVp, mA, mAs accuracy, MTF/DQE values) to the predicate devices. The image quality, for instance, is implicitly compared to "diagnostic quality images as good as our predicate generator/panel combination."
- For the digital X-ray receptor panels used within the system (Konica Minolta Wireless Detector SKR3000), their prior FDA clearances would have involved their own ground truth evaluations, but those details are not provided in this document.
The sample size for the training set:
- Not applicable, as this is an X-ray imaging system, not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as this device does not utilize a training set.

Summary

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February 1, 2021

Image /page/0/Picture/1 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 seal on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

SEDECAL SA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K203537

Trade/Device Name: Proteus XR/f, Models ST and ET, Multirad NET Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: December 1, 2020 Received: December 3, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K203537

Device Name

Proteus XR/f , Models ST and ET, Multirad and Multirad NET Radiographic Systems

Indications for Use (Describe)

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

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510(k) Summary: 510(k) Number K203537

Image /page/3/Picture/1 description: The image is a logo for SEDECAL. The logo is a teal rounded rectangle with white text and a white icon. The icon is a person sitting at a desk. The text is "SEDECAL" in all caps.

SEDECAL SA C/ Pelaya, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete, Madrid España (Spain) Tel .- +34 91 6280544 Fax.- +34 91 6280574 Date Prepared: February 1, 2021 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

1. Identification of the Device:
  Trade/Device Name: Proteus XR/f , Models ST and ET, Multirad and Multirad NET Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Codes: KPR, MQB. Common/Usual Name: Diagnostic X-Ray System
1. Equivalent legally marketed device: K090279 Trade/Device Name: Sedecal "Millennium Plus Digital Diagnostic X-Ray System" Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Codes: KPR, MQB. Common/Usual Name: Digital Diagnostic X-Ray System
1. Reference device: We employ this cleared device without modification: Trade/Device Name: Konica Minolta Wireless Detector SKR3000 Submission number: K182688 Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
1. Indications for Use: These radiographic systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
1. Description of the Device: Proteus Radiographic System, Models XR/f ST and XR/f ET; MULTIRAD and MULTIRAD NET. These radiographic systems are designed for general radiography in hospitals,

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clinics, radiology imaging centers and medical practices. It is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Patients may be physically abled, disabled, immobilized or in state of a shock. The Radiographic Systems are not intended for mammography applications. If children are to be examined, they should always be accompanied by an adult.

Image receptor, SKR3000 Seriesincluded in K182688	Image acquisition SWincluded in K182688
AeroDR 2 1417S (AeroDR P-52)
AeroDR 3 1417HD (AeroDR P-61)	CS-7
AeroDR 3 1717HD (AeroDR P-71)
AeroDR 3 1012HQ (AeroDR P-81)

All functions, displays and controls are logically arranged, easily accessible and identified to prevent confusion. Technique factors and functions are selected on the Control Console CS- 7. The Radiographic Systems Proteus XR/f ST and Proteus XR/f ET units employ a tube stand that supports the X-ray source assembly with the control panel, radiographic table for patient positioning and Wall Stand.

	MULTIRAD	PROTEUS XR/fST	MULTIRAD NET	PROTEUS XR/f ET
RAD Table	MULT-FWFTTD		NET4000-ST
WallStand	MILL-WBSorMULT-WBS	MILL-WBS	MILL-WBSorMULT-WBS	MILL-WBS
ImageSystem	Not included.Ready to beinterfaced withany imageacquisition systemafter performingthe task relatedwith the interface.	Konica Minolta(See tableabove) with CS-7Software	Not included. Ready tobe interfaced with anyimage acquisitionsystem afterperforming the taskrelated with theinterface.	Konica Minolta(See table above)with CS-7Software
TubeStand	MULT-FMTS
Generator	SHFR Series 50 KW, 65 KW, or 80 KW
Collimator	Ralco R 225 DHHS

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DAP	VacuDAP-OEM
Meter

Tube stand MULT-FMTS includes Control Panel and X-ray source assembly. Column can be moved horizontally with a manual movement trough the rail and rotate on its vertical axis between ± 180 °, with detents at -90º, 0º and 90º position. Dosimeter device and Mechanical tracking Link to center the image receptor of the RAD table with the tube stand are optional items.

The Control Panel is ergonomically built, equipped with logically arranged and easily accessible controls. Column movements are driven by the Control Panel hand-grips. Brakes to allow vertical, horizontal, rotational and transversal travels are released by a slight thumb pressure on the control push-buttons. The control panel includes a SID Display to indicate Source Image Distance and Angle Display to indicate the angle between X-ray source assembly and image receptor. The system includes a Dose Area Product Measuring System, Model VacuDAP-OEM made by Vacutec.

Characteristic	K090279 Trade/Device Name: Sedecal"Millennium Plus Digital Diagnostic X-RaySystem"	Proteus XR/f , Models ST and ET, Multirad andMultirad NET Radiographic Systems
Indications forUse	These Digital Radiographic Systems areintended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other bodyparts. Applications can be performed with thepatient sitting, standing, or lying in the proneor supine position	These radiographic systems are intended foruse by a qualified/trained doctor or technicianon both adult and pediatric subjects for takingdiagnostic radiographic exposures of the skull,spinal column, chest, abdomen, extremities,and other body parts. Applications can beperformed with the patient sitting, standing,or lying in the prone or supine position.(Essentially the same. Wording allows forboth digital and traditional versions)
Photo	Image: Sedecal "Millennium Plus Digital Diagnostic X-Ray System"	Image: Proteus XR/f Radiographic System
DigitalReceptorpanel/panelsizes	Canon modelsModel 40G: K023750Model 40C: K031633Model 50G: K031447Model 50C: K060433	Konica Minolta Wireless DetectorSKR3000, K182688
Characteristic	K090279 Trade/Device Name: Sedecal"Millennium Plus Digital Diagnostic X-RaySystem"	Proteus XR/f, Models ST and ET, Multirad andMultirad NET Radiographic Systems
Panelproperties	$160 \mu m$ , 2208 × 268814 x 17 panel size, 12 bit	$100 \mu m / 200 \mu m$ 1,994 x 2,430.14 x 17 and 17 x 17 panel sizes, 16 bit.
Typ MTF/DQE	0.70 @ 1 lp/mm0.30 @ 1 lp/mm	0.53 at 1cycle/mm0.51 at 1 cycle/mm Similar performance
Tube mount	Wall/Floor Suspension	SAME
ImageacquisitionSoftware	Canon control software CXDI-NE	Konica Minolta CX-7 provided with panel
Panel Interface	Ethernet	SAME or Wi-Fi wireless
Meets USPerformanceStandard	YES21 CFR 1020.30 Diagnostic x-ray systems andtheir major components.21 CFR 1020.31 Radiographic equipment.	SAME
X-raygenerator	SHF Family Output power: 32, 40 kW, 64 kW,80 kW.	SHFR Family Output power: 50 KW, 65 KW,80 KW SIMILAR RANGE OF OUTPUT POWER.
	kVp From 40 kV to 125 kV or 150 kV in 1 kVsteps. Accuracy: ±(3% + 1 kVp)	kVp From 40 kV to 150 kV in 1 kV stepsAccuracy: ±(3% + 1 kVp)
	mA From 10 mA to 800 mA through thefollowing mA stations:10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, 100,125, 160, 200, 250, 320, 400, 500, 640, 800.(Depending on the Generator model)Accuracy: ±(4% + 1 mA)	mA From 10 mA to 800 mA through thefollowing mA stations:10, 12.5, 16, 20, 25, 32, 40, 50, 65, 80, 100,125, 160, 200, 250, 320, 400, 500, 650, 800.(Depending on the Generator model)Accuracy: ±(4% + 1 mA)
	mAs Product of mA x Time values from 0.1mAs to 500 mAs (640 mAs on request)Accuracy: ±(10% + 0.2 mAs	mAs Product of mA x Time values from 0.1mAs to 650 mAsAccuracy: ±(10% + 0.2 mAs
Collimator	Ralco R 302/A DHHS (Manual Collimator)	Ralco R 225 DHHS (Manual Collimator)(updated version of collimator)
Power Source	Mains operated.	SAME

Substantial Equivalence Chart

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1. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new device is as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination.
1. Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket

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Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014. Cybersecurity aspects are covered in the digital panel, cleared separately in K182688. The digital panel software employed was already reviewed by FDA in 510(k)s noted in "reference devices" above. Labeling was developed and information provided in accordance with this FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Druq Administration Staff, November 2017. Labeling also includes reference to the Image Gently website (http://www.imagegently.org/). Because the device contains wireless technology, we consulted Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, AUGUST 2013 and we incorporated those recommendations into our labeling. Wireless aspects pertain to the digital x-ray receptor panel cleared separately in K182688.

The Radiographic System Proteus XR/f has been tested to be in compliance with the following International Standards:

a) 21 CFR 1020.30 Diagnostic x-ray systems and their major components and 21 CFR 1020.31 Radiographic equipment. A product report for the new SHFR generator series was previously submitted. The collimator is certified separately by the manufacturer Ralco.
b) IEC 60601-1:2005+A1:2012 (Edition 3.1) Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance.
c) IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment Collateral Standard: Electromagnetic compatibility Requirements and tests.
d) IEC 60601-1-3:2008+A1:2013 (Edition 2.1) Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
e) IEC 60601-2-54:2009+A1:2015 (Edition 1.2) Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy.
1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
1. Conclusion: After analyzing bench and clinical tests, it is the conclusion of Sedecal SA. that the new Radiographic Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

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.