The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition. including Computed Tomography (CT), to support treatment planning.

Solstice™ SRS Immobilization System (when used with headrest):

The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:

Device Description

The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.

The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle.

The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems.

The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients.

AI/ML Overview

The provided text describes premarket notification K182079 for the Solstice™ SRS Immobilization System/Solstat™ Immobilization System/Solstice™ Thermoplastic Mask. It does not contain information about a study proving the device meets acceptance criteria in the manner requested, particularly regarding clinical effectiveness studies involving human readers or expert consensus on ground truth.

However, it does provide acceptance criteria related to device performance in terms of patient immobilization accuracy, which is substantiated by non-clinical testing.

Here's an attempt to extract and frame the available information in the requested format, clearly stating where information is "Not Applicable" or "Not Provided" based on the document:

Device: Solstice™ SRS Immobilization System / Solstat™ Immobilization System / Solstice™ Thermoplastic Mask

Purpose of Testing (Non-Clinical): To substantiate the immobilization performance for Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapy (SRT), and suitability for Surface Guided Radiation Therapy (SGRT) and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Goal)	Reported Device Performance
Solstice SRS Immobilization System: Intrafraction movement during a 5-minute scanning window is less than 1.000mm.	"intrafraction movement during a 5-minute scanning window to the 99.73% Confidence Interval is less than 1.000mm." (Page 8)
Solstice SRS Immobilization System: Intrafraction movement during a 30-minute scanning window is less than 1mm.	"intrafaction movement during a 30 minute scanning the 95.45% confidence intervals is less than 1mm." (Page 8)
Solstat Immobilization System: Reproduce patient position to under 3 millimeters within a treatment cycle.	"When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle." (Listed as a feature/performance characteristic in comparison table, Page 6) - Note: This is stated as a capability, the document does not explicitly state a study proving this specific 3mm reproduction. It is more of a design claim based on the features.
Solstat Immobilization System & Open-Face Thermoplastic Mask: Suitable for Surface Guided Radiation Therapy (SGRT)	"Solstat, and the Open-Face thermoplastic mask can be used for Surface Guided Radiation Therapy (SGRT) as the Region of Interest (ROI) is able to be seen by the camera system." (Page 8) - Note: This is stated as a capability based on testing with VisionRT's AlignRT system.
Solstat Device: MR Safety (RF heating, magnetically induced torque, magnetically induced displacement force)	"The Solstat device was tested for image artifact using ASTM Standard F2119-07 as guidance and is considered MR Safe." (Page 7)

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

Sample Size: Not explicitly stated for the non-clinical tests. The data points presented for the Solstice device are statistical confidence intervals (99.73% and 95.45%), but the raw number of measurements or repetitions for these tests is not provided.
Data Provenance: Non-clinical testing data; likely internal laboratory testing (MEDTEC Inc. dba CIVCO MEDICAL SOLUTIONS). The country of origin and whether it was retrospective or prospective is not specified, but non-clinical tests are generally prospective.

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

Not Applicable / Not Provided. The "ground truth" for these performance claims appears to be derived from physical measurements using camera systems (e.g., VisionRT's AlignRT system) and standard test methods (e.g., ASTM F2119-07 for MR safety), rather than human expert interpretation of medical images.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. This concept (2+1, 3+1, none) typically applies to human reader studies where expert disagreement on ground truth needs resolution. Here, it's about physical performance measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted as this is a device for patient immobilization and positioning, not an AI image analysis device requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance

Not Applicable. The device itself is a physical immobilization system. The "performance" relates to its mechanical stability and ability to maintain patient position, measured non-clinically. It does not employ an algorithm in the sense of AI for diagnostic or clinical decision support.

7. Type of Ground Truth Used

Physical Measurements and Standard Test Methods.
- For Solstice: Intrafraction movement measured by camera systems (e.g., VisionRT's AlignRT system).
- For Solstat MRI safety: Compliance with ASTM F2119-07.

8. Sample Size for the Training Set

Not Applicable / Not Provided. There is no "training set" in the context of this physical device's non-clinical performance evaluation. This concept is relevant for machine learning models.

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

Not Applicable / Not Provided. See point 8.

Summary

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September 7, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and most prominent.

MEDTEC Inc. dba CIVCO MEDICAL SOLUTIONS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313

Re: K182079

Trade/Device Name: Solstice™ SRS Immobilization System; Solstat™ Immobilization System; Solstice™ Thermoplastic Mask Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: July 31, 2018 Received: August 2, 2018

Dear Mr. Job:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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,

Jeff Ballew

for Robert A. 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) K182079

Device Name

(1 & 2) Solstice™ SRS Immobilization System (3) Solstat™ Immobilization System ; Solstice™ Thermoplastic Mask

Indications for Use (Describe)

Solstice™ SRS Immobilization System (when used with customizable cushion):

Solstice™ SRS Immobilization System (when used with headrest):

Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:

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)

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Image /page/3/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and consists of the word "CIVCO" in a sans-serif font, with a small blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

Section 5 - 510(k) Summary

A. Submitter Information

Submitter Name & Address:	MEDTEC, Inc.d/b/a CIVCO Medical Solutions and CIVCO Radiotherapy1401 8th St. SEOrange City, IA 51041
Contact Person:	Alena Newgren, Regulatory SpecialistTelephone: 319-248-6650, Fax: 877-613-6300alena.newgren@civcort.com
Date Summary Prepared:	May 21, 2018
Trade Name:	Solstice™ SRS Immobilization System; Solstat™Immobilization System; Solstice™ Thermoplastic Mask
Common Name:	Tilting Head Fixation System; Static Head Fixation System;Open-Face Thermoplastic Mask
Classification Names & Numbers:	Medical charged-particle radiation therapy system (892.5050)System, Nuclear Magnetic Resonance Imaging (892.1000)
Device Class:	Class II
Review Panels:	Radiology
Product Codes:	IYE, LNH

B. Predicate Devices

The proposed devices are substantially equivalent to the following predicate devices:

Predicate Devices	Manufacturer
Systems Prone Head and Neck Immobilization System included inCDR Systems Precision Patient Positioning System (K122888)	CDR Systems, Inc.

The purpose of this 510(k) is to 1) release new SRS/SRT/SGRT compatible system, 2) and 2) identify intended use statements for the proposed devices. CIVCO Radiotherapy has not submitted any prior submissions for the proposed devices.

C. Device Descriptions

The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level

www.CivcoRT.com

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Image /page/4/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a bold, sans-serif font. A small blue circle is placed above the "V" in CIVCO. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.

DeviceFamily	Part No.	Device Name
Tilting HeadFixationSystem	CHS03	Solstice SRS Immobilization Systemwith Type-S Base
	CHS04	Solstice SRS Immobilization Systemwith Posi Style Base
	Static HeadFixationSystem	CHS05
CHS06		Solstat Immobilization System with PosiStyle Base
Open FaceThermoplasticMask		MTAPCIN1832SG
	MTAPCIN1832SG	Thermoplastic Mask, Narrow Frame, OpenFace

www.CivcoRT.com

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Image /page/5/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a light blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

D. Indications for Use/Intended Use Statements

Indications for Use:

Solstice™ SRS Head Immobilization System (when used with customizable cushion): The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

Solstice™ Head Immobilization System (when used with headrest):

The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.

Solstat Head Immobilization System and Open-Face Thermoplastic Mask:

Device-Specific Intended Use:

Solstice SRS Head Immobilization:

The device is intended to immobilize the patient by encapsulating the head and provide corrective tilting of the head for treatment and simulation.

Solstat Head Immobilization System and Open-Face Thermoplastic Mask: The device is intended to immobilize the patient by encapsulating the head for treatment and simulation such as MRI.

E. Comparison of Technological Characteristics

Technological characteristics that have changed between the proposed and predicate devices include changes in design and materials. The proposed Solstice Tilting Head Fixation System and predicate allow SRS/SRT and use headrests and thermoplastic masks, but the proposed Tilting device allows for infinitely adjustable angles from -5° to +5°, either used with customizable cushion (for SRS/SRT) or reusable headrest, and open-face mask to be used with camera systems and SGRT. Both the Solstat Static Head Fixation System and predicate system allow for patient immobilization, but the proposed device allows for use of customizable cushion and open-face mask to be used with camera

www.CivcoRT.com

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Image /page/6/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a bold, sans-serif font. A small blue circle is placed above the "V" in "CIVCO". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

systems and surface guided radiation therapy(SGRT). Different materials were used to manufacture the proposed devices and were selected with MR safety and effectiveness considerations.

#	Feature	Predicate Device(CDR Systems ProneHead and NeckImmobilization System)	CIVCO Device(Solstice SRSImmobilization System)	CIVCO Device (SolstatImmobilization Systemand Open-FaceThermoplastic Mask)
1	Indications forUse	CDR Systems PrecisionPatient Positioning System isindicated to assist in theproper positioning of patientsfor radiation therapy andradiosurgery simulation andtreatment including electron,photon and protontreatments. Place a cleansheet over the device toensure a clean device frompatient to patient.	Tilting Head ImmobilizationSystem (when used withcustomizable cushion):The device is indicated toposition and/or immobilizeadult and pediatric patientsundergoing radiation therapyof the head, brain, and neck,including StereotacticRadiosurgery (SRS),Stereotactic Radiotherapy(SRT), Surface GuidedRadiation Therapy (SGRT)and electron, photon, andproton treatments. Thedevice is also used duringimage acquisition, includingComputed Tomography (CT),to support treatmentplanning.Tilting Head ImmobilizationSystem (when used withheadrest):The device is indicated toposition and/or immobilizeadult and pediatric patientsundergoing radiation therapyof the head, brain, and neck,including Surface GuidedRadiation Therapy (SGRT)and electron, photon, andproton treatments. Thedevice is also used duringimage acquisition, includingComputed Tomography (CT),to support treatmentplanning.	The device is indicated toposition and/or immobilizeadult and pediatric patientsundergoing radiation therapyof the head, brain, and neck,including Surface GuidedRadiation Therapy (SGRT)and electron, photon, andproton treatments. The deviceis also used during imageacquisition, includingComputed Tomography (CT)Magnetic Resonance (MR)Imaging, to support treatmentplanning.
2	Classification	Class II (K122888)	Class II	Class II
3	Features	A headboard that attaches toa baseplate that locates ontoa couch tabletop, onto a CDR	The Tilting Head FixationSystem can be attached tothe treatment or simulation	The Static Head FixationSystem can be attached tothe treatment or simulation
#	Feature	Predicate Device(CDR Systems ProneHead and NeckImmobilization System)	CIVCO Device(Solstice SRSImmobilization System)	CIVCO Device (SolstatImmobilization Systemand Open-FaceThermoplastic Mask)
		Couch Overlay or CouchExtension and providesadjustable positive andnegative tilt for patient'shead. Can be used forsupport of a patient's head insupine or prone position. Alow temperaturethermoplastic mask can beused for additionalimmobilization.	couch, extension, or overlayalong with other optionalpositioning andimmobilization devices andaccessories. Thethermoplastic mask isattached onto the device andis molded to the patient'sfacial anatomy. The patientlies directly on the treatmentsurface in the supineposition.	couch, extension, or overlayalong with other optionalpositioning andimmobilization devices andaccessories. Thethermoplastic mask isattached onto the device andis molded to the patient'sfacial anatomy. The patientlies directly on the treatmentsurface in the supine position.
4	Materials	Carbon fiber/epoxy laminatematerial with foam core.MR Safe - Kevlar/epoxylaminate material with foamcore.	Carbon Fiber, Black Acetal,Kydex-T, Nylon,Polycarbonate	Static Head Fixation(MR):Kydex-T, Nylon,PolycarbonateThermoplastic Mask(MR):Polycaprolactone,Polycarbonate
5	Device BodyContactCategory	Limited contact duration (<24hours) for surface devices(skin).	Limited contact duration (<24hours) for surface devices(skin).	Limited contact duration (<24hours) for surface devices(skin).
6	Immobilization	SRS/SRT (marketing)	When used withcustomizable cushion andthermoplastic mask, thesystem can immobilize thepatient to under 1millimeter(SRS/SRT).	When used with customizablecushion and thermoplasticmask, the system canreproduce the patient positionto under 3 millimeters within atreatment cycle.
7	Performance	SRS/SRT, MR	SRS/SRT, SGRT, Adult &Pediatrics	MRI, SGRT, Adult &Pediatrics

www.CivcoRT.com

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Image /page/7/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and consists of the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller font. The logo is simple and modern, and the blue color gives it a professional and trustworthy look.

F. Non-Clinical Testing

Non-clinical testing was completed to confirm that the proposed devices are as safe and effective as the predicate devices and to confirm that the changes in technological characteristics do not raise any new issues of safety or effectiveness.

For the Solstat Device, a scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force. The Solstat device was tested for image artifact using ASTM Standard F2119-07 as guidance and is considered MR Safe.

www.CivcoRT.com

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Image /page/8/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a sans-serif font. Above the "V" is a light blue circle. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.

For the Solstice Device, non-clinical testing using camera systems was done to substantiate the use for Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapv (SRT). Based on data obtained we can state that intrafraction movement during a 5-minute scanning window to the 99.73% Confidence Interval is less than 1.000mm. Additionally, based on the data obtained, we can state that intrafaction movement during a 30 minute scanning the 95.45% confidence intervals is less than 1mm.

Therefore, the Tilting Head Fixation System appropriately immobilizes a patient for SRS/SRT such that the intrafractional shifts are less than 1mm within a 5-mintute window with 99.73% confidence, and within a 30-minute window with 95.45% confidence.

Based on testing with VisionRT's AlignRT system, Solstat, and the Open-Face thermoplastic mask can be used for Surface Guided Radiation Therapy (SGRT) as the Region of Interest (ROI) is able to be seen by the camera system.

The devices are intended for limited contact duration (<24 hours) for surface devices (skin). Biocompatibility testing was completed for patient-contacting materials in accordance with ISO 10993-5 and ISO 10993-10.

G. Conclusion

This premarket submission for the Tilting Head Fixation System, Static Head Fixation System, and Open-Face Thermoplastic Mask has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

www.CivcoRT.com

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.