ScanX Touch/ScanX Duo Touch by Air Techniques, Inc.

The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

Device Description

The ScanX Touch is a device that scans photostimulable phosphor storage plates that have been exposed in place of X-ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure

AI/ML Overview

The provided text describes the Air Techniques ScanX Touch/ScanX Duo Touch, a device for scanning and processing digital images from Phosphor Storage Plates (PSPs) in dental applications. The information focuses on demonstrating substantial equivalence to a predicate device (ScanX Intraoral View, K170733) rather than a comprehensive study proving the device meets specific performance acceptance criteria for a novel AI algorithm.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this document as it pertains to a traditional medical device clearance, not an AI-driven one.

Here's a breakdown of the information that can be extracted, aligning with the closest relevant details provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily framed around demonstrating substantial equivalence to the predicate device in terms of image quality and functional specifications. The "acceptance criteria" here are implicitly meeting or exceeding the predicate's performance in key imaging metrics.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (ScanX Touch/ScanX Duo Touch)	Predicate Device Performance (ScanX Intraoral View, K170733)
Indications for Use	Intended for scanning and processing digital images exposed on PSPs in dental applications.	SAME
Mechanical Design	SAME as Predicate Device (scans plates in two orthogonal directions using a 650 nm laser)	The exposed and unwrapped plates are scanned in two orthogonal directions using a laser with a wavelength of approximately 650 nm.
Electrical Design	SAME as Predicate Device (light 380 nm collected proportional to X-ray photons, formed into image for display/storage)	Light with a wavelength of approximately 380 nm is from the plate in proportion to the number of captured X-ray photons. This light is collected and formed into an image that may be viewed on a video display and stored for later recovery in a computer memory.
Image Scanning	Laser/Photomultiplier Tube	SAME
Erasing Residual Image	Inline erasing function	SAME
Viewing the Image	7.0″ diagonal Touch Screen (preview only); diagnostic viewing on external monitor with computer and software.	4.3″ Touch Screen (preview only); diagnostic viewing on external monitor with computer and software.
Transport / Feed Mechanism	SAME as Predicate Device (beltways, continuous feed)	The plates are transported by "beltways" down the axis of the cylinder past the slot. The motion of the laser and plates provides the two orthogonal scan directions. This is a continuous feed device that allows successive plates to be loaded as soon as the previous plates have moved past the slot.
Phosphor Plates	Operates with the same Dental intraoral size and material PSPs; includes RFID identification system.	Dental intraoral PSPs: Size 0 (22x35mm), Size 1 (24x40mm), Size 2 (31x41mm), Size 3 (27x54mm), Size 4 (57x76mm).
Image Quality (Resolution)	Theoretical resolutions: 10, 20, 25 or 40 Lp/mm	SAME
MTF (Modulation Transfer Function)	More than 46% at 3 Lp/mm (essentially the same)	More than 45% at 3 Lp/mm
DQE (Detective Quantum Efficiency)	More than 7.2% at 3 Lp/mm (essentially the same)	More than 7.5% at 3 Lp/mm
Image Data Bit Depth	16 bits	SAME
Imaging Software	DBSWIN/VistaEasy (updated in K190629)	DBSWIN/VistaEasy (cleared in K161444, updated in K190629)
User Interface	Used by dentists and authorized dental auxiliary personnel.	SAME
Energy Source AC	100 to 240VAC, 50/60 Hz	SAME
Electrical Safety Standards	IEC 60601-1 Electrical Safety Medical Devices, UL Listed.	EN 61010-1:2010 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements.
EMC Testing	IEC 60601-1-2 EMC Medical Devices; Complies with EN 61326-1:2013, FCC rules part 15 (RFID).	EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements. General requirements.
Patient Contamination Prevention	Uses identical single-use barrier envelopes as predicate device.	Single patient use barrier envelope encloses the imaging plate while in the patient's mouth.

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

Sample Size: The document mentions that "Test images were acquired on the new device and on the predicate device." However, a specific number of images or cases used for this comparison is not provided.
Data Provenance: Not explicitly stated, but the testing was conducted by Air Techniques, Inc. likely within their facilities or through contracted labs (e.g., UL). There's no mention of country of origin for the data or whether it was retrospective or prospective in detail beyond the acquisition of "test images."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: "a licensed dentist" (singular)
Qualifications: "licensed dentist" (no further details such as years of experience or specialization are given).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The evaluation was a single-reader assessment where a licensed dentist answered specific questions in the affirmative regarding the images. There was no mention of a consensus process among multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation involved a single licensed dentist.
Effect Size of Human Readers with/without AI: Not applicable, as this device itself is not an AI algorithm but an imaging hardware and processing system. The study did not assess human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. The device is hardware for image acquisition and initial processing. The "standalone" testing referred to in the document relates to the device's ability to operate and save images independently if the IT network goes down, not an AI algorithm's standalone diagnostic performance.

7. The Type of Ground Truth Used

Type of Ground Truth: "Expert assessment/satisfaction." A licensed dentist evaluated the images for representativeness, diagnostic usefulness, and absence of misleading artifacts, and comparability to the predicate. This is a subjective expert evaluation rather than an objective "ground truth" derived from pathology or definitive outcomes data.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document does not describe an AI algorithm that was "trained." The device is an image acquisition and processing system.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set or an AI algorithm that requires one.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.

August 21, 2019

Air Techniques, Inc. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K191623

Trade/Device Name: ScanX Touch/ScanX Duo Touch Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: June 14, 2019 Received: June 18, 2019

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191623

Device Name ScanX Touch/ScanX Duo Touch

Indications for Use (Describe)

The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

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

Description 666 (Part 2: SPFL 001 Support B)

| | 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Air Techniques. The logo is blue and features the words "AIR TECHNIQUES" in a bold, sans-serif font. Above the word "TECHNIQUES" is the phrase "equipped for life" in a smaller font. The logo is simple and modern, and it conveys a sense of quality and reliability.

Air Techniques, 1295 Walt Whitman Road Melville, NY 11747 510(k) Summary K191623

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

Date Summary Prepared: August 15, 2019 1.
1. Submitter's Identification: AIR TECHNIQUES, INC. 1295 Walt Whitman Road Melville, NY 11747 Tel: +1 (516) 214-5000 Internet: www.airtechniques.com

Contact: Warren Cheesman, Director of R&D Email: Warren.Cheesman@airtechniques.com AIR TECHNIQUES, INC. 1295 Walt Whitman Road Melville, NY 11747 Tel: +1 (516) 214-5550

1. Device Name:

	Trade / Proprietary Name:	ScanX Touch/ScanX Duo Touch
	Regulation Number:	21 CFR 872.1800
	Regulation Name:	Extraoral source x-ray system
	Regulatory Class:	II
	Product Code:	MUH

1. Legally Marketed Predicate Device Information: K170733 Trade / Device Name: ScanX Intraoral View Manufactured by DUERR DENTAL AG Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: ll Product Code: MUH
1. Device Description: The ScanX Touch is a device that scans photostimulable phosphor storage plates that have been exposed in place of X-ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The

{4}------------------------------------------------

Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure

1. Indications for use: (Rx Only) The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
1. Safety and Effectiveness:

The ScanX Touch is a device that scans photostimulable phosphor storage plates that have been exposed in place of X-ray film and allows the resulting images to be displayed on a personal computer monitor. Safety concerns associated with the ScanX Touch were addressed by safety testing the device with UL to IEC 60601-1 third edition (Electrical Safety), IEC 60601-1-2 (EMC) and IEC 60825-1 (Laser Safety). Design changes and risks associated with the introduction of the ScanX Touch / ScanX Duo Touch were properly mitigated by Air Techniques' cGMP compliant Quality Management System, change control processes, risk assessments, and product validation. The ScanX Touch contains a Class 1 Laser Device as defined by 21 CFR 1040.10. Installation and operation manuals are provided with instructions for safe use and servicing of the ScanX Touch. The ScanX Touch is a non-patient contact Class II medical device.

1. Substantial Equivalence to Predicate Device Summary
  Air Techniques' ScanX Touch is identical in function and intended use to the ScanX Intraoral View manufactured by Duerr Dental AG, whose dental units are in commercial distribution and are FDA cleared under 510K # K170733. The same engineering principles are used in both devices. ScanX Touch and the ScanX Intraoral View (predicate) both capture, digitize, and process intraoral X-ray images that are stored in imaging plate recording media.
1. Table of comparison to Legally Marketed Device:

{5}------------------------------------------------

ComparisonCriteria	Predicate Device: ScanX IntraoralView, K170733, Duerr Dental AG	New Device: ScanX Touch/ScanX Duo Touch
Photo	Image: ScanX Intraoral View, K170733, Duerr Dental AG	Image: ScanX Touch/ScanX Duo Touch
Indications forUse	The ScanX Intraoral View isintended to be used for scanningand processing digital imagesexposed on Phosphor StoragePlates (PSPs) in dentalapplications.	The ScanX Touch/ScanX Duo Touch isintended to be used for scanning andprocessing digital images exposed onphotostimulable phosphor storage plates indental applications. (SAME)
MechanicalDesign	The exposed and unwrappedplates are scanned in twoorthogonal directions using a laserwith a wavelength ofapproximately 650 nm.	SAME as Predicate Device
ElectricalDesign	Light with a wavelength ofapproximately 380 nm is from theplate in proportion to the numberof captured X-ray photons. Thislight is collected and formed intoan image that may be viewed on avideo display and stored for laterrecovery in a computer memory.	SAME as Predicate Device
ImageScanning	Laser/Photomultiplier Tube	SAME as Predicate Device
Erasing theresidual imagefollowingscanning forplate reuse	The residual image is erased in thescanner by an inline erasingfunction.	SAME as Predicate Device
ComparisonCriteria	Predicate Device: ScanX IntraoralView, K170733, Duerr Dental AG	New Device: ScanX Touch/ScanX Duo Touch
Viewing theimage	4.3″ Touch Screen. The touchscreen only shows a previewwhich serves to provide an initialimpression of the final X-rayimage. For the purposes ofdiagnosis, the X-ray image mustbe viewed on a diagnosticmonitor. The scanned images aredisplayed on an internal LCD or anexternal monitor using a computerand user software including imagestorage, retrieval andmanipulation.	SAME as Predicate Device, except the TouchScreen measures 7.0″ diagonal instead of4.3".
Transport /feedmechanism	The plates are transported by"beltways" down the axis of thecylinder past the slot. The motionof the laser and plates providesthe two orthogonal scandirections. This is a continuousfeed device that allows successiveplates to be loaded as soon as theprevious plates have moved pastthe slot.	SAME as Predicate Device
PhosphorPlates	Dental intraoralSize 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mmSize 3: 27 x 54 mmSize 4: 57 x 76 mm	The ScanX Touch/ScanX Duo Touch operateswith the same (Dental intraoral) size ANDmaterial Phosphor Plates as the ScanXIntraoral View. The ScanX Touch also includesan RFID Phosphor Plate identification systemwhich requires that the Phosphor Plate has anRFID tag attached to the non-imaging side ofthe Plate.
Image Quality	Theoretical resolutions: 10, 20, 25or 40 Lp/mm	SAME as Predicate Device
MTF	More than 45% at 3 Lp/mm	More than 46% at 3 Lp/mm (essentially thesame)
DQE	More than 7.5% at 3 Lp/mm	More than 7.2% at 3 Lp/mm(essentially the same)
Image data bitdepth	16 bits	16 bits, SAME
Body Size andWeight	380 x 410 x 450 mm (W x L x H)19.5 kg 42.99 lbs.	220 X 320 X 270 mm8.0 kg, 17.6 lbs.Slightly smaller/lighter
ComparisonCriteria	Predicate Device: ScanX IntraoralView, K170733, Duerr Dental AG	New Device: ScanX Touch/ScanX Duo Touch
ImagingSoftware	DBSWIN/VistaEasy as cleared inK161444, updated in K190629	SAME DBSWIN/VistaEasy have been updatedin K190629
User Interface	It will be used by dentists andauthorized dental auxiliarypersonnel.	SAME as Predicate Device
Energy SourceAC	100 to 240VAC, 50/60 Hz	SAME as Predicate Device
Electricalsafetystandards	ΕΝ 61010-1:2010 SafetyRequirements for ElectricalEquipment for Measurement,Control, and Laboratory Use - Part1: General Requirements	IEC 60601-1 Electrical Safety Medical Devices.UL Listed
EMC Testing	ΕΝ 61326-1:2013 Electricalequipment for measurement,control and laboratory use. EMCrequirements. Generalrequirements	IEC 60601-1-2 EMC Medical DevicesAlso complies with EN 61326-1:2013, EMCRequirements for Lab use and FCC rules part15 (RFID feature)
PatientContaminationprevention	Single patient use barrierenvelope encloses the imagingplate while in the patient's mouth.	We use the IDENTICAL single use barrierenvelopes as the Predicate Device

{6}------------------------------------------------

{7}------------------------------------------------

The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.

1. Summary of non-clinical performance testing: Prior to performance testing, labeling was developed to mitigate cybersecurity risks and risks to pediatric patients. The following guidance documents were consulted: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff OCTOBER 2014 and Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff NOVEMBER 2017. Risk analysis and software validation was successfully performed. EMC Testing according to IEC 60601-1-2 was successfully performed. Electrical safety testing according to IEC 60601-1 was successfully performed. Laser safety testing was performed according to IEC IEC 60825-1, Safety of laser products. The unit is UL listed. MTF and DQE image performance testing was performed with reference to IEC 62220-1:2003. Noise power spectrum measurements were documented. These FDA guidance documents were employed: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005 AND Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016. The device was also tested by UL for compliance with FCC Part 15 subpart C. The testing was successful. This was required because of the internal RFID feature. The device contains an NFC radio used for RFID. Test images were acquired on the new device and

{8}------------------------------------------------

on the predicate device. They were presented to a licensed dentist for his professional evaluation. The following questions were answered in the affirmative:

The images acquired using the ScanX Duo Touch displayed in the dental imaging software are representative of customary intraoral X-rays.

The images acquired using the ScanX Duo Touch are useful for a diagnostic purpose.

The images acquired using the ScanX Duo Touch do not display any misleading artifacts that would hinder my ability to diagnose from.

The images acquired using the ScanX Duo Touch are comparable to those images acquired using the ScanX Intraoral View.

1. Summary of clinical performance testing: Not required to establish substantial equivalence.
1. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Air Techniques, Inc. concludes that the ScanX Touch is safe and effective and substantially equivalent to the predicate device as described herein.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.