MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process images from MRI systems to

provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning, and to
derive contours for input to radiation treatment planning by assisting in localization and definition of healthy anatomical structures.
MRI Planner is not intended to automatically contour tumor clinical target volumes.
MRI Planner is indicated for radiotherapy planning of adult patients for primary and metastatic cancers in the brain and head-neck regions, as well as soft tissue cancers in the pelvic region.
MRI Planner generates synthetic CT images for radiation attenuation estimation purposes for the pelvis, brain and head-neck regions only. MRI Planner generates automatically derived contours of the bladder, colon and femoral heads, for prostate cancer patients only.

Device Description

The product MRI Planner is a stand-alone software providing information to the treatment planning process prior to radiotherapy. Based on a DICOM MR image stack, the software generates synthetic CT images that can be used for attenuation calculations in radiotherapy treatment planning for the pelvis, brain and head-neck regions. In addition, the software also generates contours of anatomical structures in the MR image stack, to be used as a starting point for the manual delineation work required in radiotherapy treatment planning. Contours are generated for prostate cancer patients only (bladder, colon and femoral heads).
MRI Planner utilizes pre-trained machine learning models to perform both the conversion to synthetic CT and the automated structure contouring. The models for synthetic CT generation was trained using a dataset comprising MR and CT images for 244 patients acquired in the treatment position at four hospitals. The model for prostate cancer patient auto contouring was trained using a dataset comprising MR images for 175 patients acquired in the treatment position at four hospitals, together with in-house generated expert manual contours. MRI Planner does not display or store DICOM images. The user is advised to use existing softwares for radiotherapy treatment planning to display and modify generated images and contours.
MRI Planner runs on a standard x86-64 compatible system with a CUDA capable NVIDIA GPU and requires Ubuntu Linux 18.04 operating system.

AI/ML Overview

This document describes the acceptance criteria and the studies conducted to prove that the MRI Planner device meets these criteria. The device is a software-only medical device intended for use by trained radiation oncologists, dosimetrists, and physicists for radiation attenuation estimation and contouring of healthy anatomical structures in radiotherapy treatment planning.

1. Table of Acceptance Criteria and Reported Device Performance

The performance of MRI Planner was evaluated through two main bench tests: a Dose Accuracy Bench Test for synthetic CT (sCT) generation and an Auto Contouring Bench Test for anatomical structure delineation.

Metric Category	Acceptance Criteria	Reported Device Performance
Dose Accuracy (Synthetic CT)
Mean Target Dose Difference (sCT-CT)	Implied: Dosimetric agreement should be high, with minimal differences between sCT and conventional CT. Specific numerical criteria are not explicitly stated as "acceptance criteria," but the reported performance is compared against a general expectation of high accuracy.	Pelvis: Average sCT-CT mean target dose difference was 0.02% ± 0.31%. Head-Neck and Brain: Average sCT-CT mean target dose difference was -0.02% ± 0.25%.
Non-Target sCT-CT Dose Difference	99% of cases should have no sub-volumes with an sCT-CT dose difference in excess of 1.0 Gy or 5% of the CT-dose.	All cases: No cases displayed any sub-volumes with sCT-CT dose differences in excess of 5% or 1.0 Gy, meeting the 99% criteria.
High Dose Gamma Evaluation (3%/3mm for Pelvis & Head-Neck; 2%/2mm for Brain)	Gamma index passing rate requirement: 99% for pelvis and head-neck, and 98% for brain.	Pelvis, Head-Neck, Brain: 100.0% of cases passed the individual passing rate criterion for all anatomical regions. Average gamma index passing rates: 99.9% (pelvis), 99.8% (head-neck), 99.8% (brain). (All surpassed the acceptance criteria)
Medium Dose Gamma Evaluation (2%/2mm for all regions)	Gamma index passing rate requirement: 99% for all anatomical regions.	Pelvis: 98.3% of cases passed the individual passing rate criterion. Head-Neck and Brain: 100.0% of cases passed the individual passing rate criterion. Average gamma index passing rates: 99.7% (pelvis), 99.5% (head-neck), 99.9% (brain). (All surpassed the acceptance criteria, except for individual cases in pelvis fell slightly below 99% in individual passing rate criterion, but the average still meets.)
Auto Contouring (Bladder, Colon, Femoral Heads for prostate cancer patients)
Dice Score (DSC) (Higher is better)	Implied: High agreement between automatically generated and manual delineations. No specific numerical acceptance criteria explicitly stated; performance is compared to generally accepted high scores for medical image segmentation.	Bladder: 0.95 ± 0.03 Colon: 0.90 ± 0.04 Femoral Head: 0.96 ± 0.01
95% Hausdorff Distance (HD) (Lower is better)	Implied: Low spatial disagreement between automatically generated and manual delineations. No specific numerical acceptance criteria explicitly stated; performance is compared to generally accepted low distances for medical image segmentation.	Bladder: 2.69 ± 1.82 Colon: 4.96 ± 3.91 Femoral Head: 2.04 ± 0.49

2. Sample Sizes and Data Provenance

For Dose Accuracy Bench Test (Synthetic CT)

Pelvis:
- Test Set Sample Size: 58 unique pelvis cancer patients.
- Data Provenance: MR (T2w) and CT images acquired in the treatment position at six different hospitals.
- Geographic Distribution: 41% of patient images from the US, 59% from outside the US.
- Demographics: 16% female, 84% male, age range 51-88 years.
- MRI Scanner Data: Acquired at six different MRI scanner models from two different vendors (1.5T and 3T field strengths).
Head-Neck-Brain:
- Test Set Sample Size: 75 unique head-neck-brain cancer patients.
- Data Provenance: MR (T1-Dixon) and CT images acquired in the treatment position at four different hospitals.
- Geographic Distribution: 55% of patient images from the US, 45% from outside the US.
- Demographics: 39% female, 64% male, age range 41-85 years.
- MRI Scanner Data: Acquired at six different MRI scanner models from two different vendors (1.5T and 3T field strengths).

For Auto Contouring Bench Test

Test Set Sample Size: 51 unique male prostate cancer patients.
Data Provenance: MR (T2w) images acquired in the treatment position at five different hospitals.
Geographic Distribution: 39% of patient images from the US, 61% from outside the US.
Demographics: Male, age range 51-88 years.

3. Number of Experts and Qualifications for Ground Truth (Auto Contouring)

Number of Experts: Two expert truthers.
Qualifications: "Expert truthers" involved in the product development and training dataset generation. No specific professional qualifications (e.g., "Radiologist with X years of experience") are provided, but their involvement in product development and training data generation suggests specialized knowledge.
Employment: Both truthers were employed by the manufacturer (Spectronic Medical AB) at the time of performing the manual delineations for the bench test.

4. Adjudication Method for Ground Truth (Auto Contouring)

Adjudication Method: Consensus approach ("using the consensus approach"). This implies the two experts worked together to agree on the final ground truth delineations.
Guidelines: The consensus was based on US clinical guidelines.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to evaluate human readers' improvement with or without AI assistance. The studies performed are standalone performance evaluations against ground truth (for auto-contouring) and conventional CT (for synthetic CT dose accuracy).

6. Standalone Algorithm Performance

Yes, standalone performance was done for both components.
- Synthetic CT Generation: The dosimetric bench tests directly evaluate the performance of the MRI Planner's generated synthetic CT images against conventional CT (which serves as a form of ground truth for dose calculation), without human intervention in the generation process.
- Auto Contouring: The auto-contouring bench tests evaluate the automatically generated delineations against expert manual delineations (ground truth), representing the algorithm's performance without human-in-the-loop during contour generation.

7. Type of Ground Truth Used

For Dose Accuracy Bench Test (Synthetic CT)

Type of Ground Truth: Dosimetric agreement was evaluated by comparing the dose calculated from synthetic CT (sCT) with dose calculated from conventional CT (CT). In this context, the conventional CT images serve as the ground truth for accurate dose calculation and attenuation estimation.

For Auto Contouring Bench Test

Type of Ground Truth: Expert consensus manual delineations. These refer to the manually generated contours of bladder, colon, and femoral heads by two expert truthers based on US clinical guidelines.

8. Sample Size for the Training Set

For Synthetic CT Generation

Training Set Sample Size: 244 patients. This dataset comprised MR and CT images.

For Auto Contouring

Training Set Sample Size: 175 patients. This dataset comprised MR images.

9. How Ground Truth for the Training Set was Established

For Synthetic CT Generation

Ground Truth Establishment: The training data for synthetic CT generation comprised paired MR and CT images. The CT images inherently serve as the ground truth for tissue properties and attenuation values. These images were acquired in the treatment position at four hospitals.

For Auto Contouring

Ground Truth Establishment: The training data for auto-contouring included MR images together with "in-house generated expert manual contours." This indicates that expert(s) within Spectronic Medical manually delineated the structures (bladder, colon, femoral heads) on the MR images to create the ground truth for training the model. The text also states that the truthers involved in the bench test were involved in the development of the product and the generation of the training dataset. It is specifically mentioned that these expert manual delineations for the training set were generated at a different time than those used for the bench test.

Summary

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Spectronic Medical AB % Per Bruhn Manager of Quality Assurance and Regulatory Affairs Karbingatan 36 Helsingborg, 25467 SWEDEN

Re: K211841

Trade/Device Name: MRI Planner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ, QKB Dated: July 22, 2022 Received: July 25, 2022

Dear Per Bruhn:

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

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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 medical devices and radiation-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

Julie Sullivan, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K211841

Device Name

MRI Planner

Indications for Use (Describe)

MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process images from MRI systems to

provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning, and to
derive contours for input to radiation treatment planning by assisting in localization and definition of healthy anatomical structures.

MRI Planner is not intended to automatically contour tumor clinical target volumes.

MRI Planner is indicated for radiotherapy planning of adult patients for primary and metastatic cancers in the brain and head-neck regions, as well as soft tissue cancers in the pelvic region.

MRI Planner generates synthetic OT images for radiation attenuation estimation purposes for the pelvis, brain and head-neck regions only. MRI Planner generates automatically derived contours of the bladder, colon and femoral heads, for prostate cancer patients only.

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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Spectronic Medical

Image /page/3/Picture/2 description: The image shows the logo for Spectronic Medical. The word "SPECTRONIC" is in large, bold, black letters with a thick black line underneath. To the right of the word "SPECTRONIC" are three diagonal pink lines. Below the black line and to the right is the word "MEDICAL" in smaller, bold, black letters.

1. 510(k) Summary

K211841

The following summary of the present 510(k) submission is provided:

Date Prepared	August 25, 2022
Contact details	Spectronic Medical ABKarbingatan 36254 67 HelsingborgSWEDEN
Contact Person	Per BruhnManager of Quality Assurance and Regulatory AffairsSpectronic Medical ABTel: +46 735 116042Email: per.bruhn@spectronic.se
Device trade name:Common Name:Classification Regulation:Classification Name:Panel:Classification:Product Code:	MRI PlannerMRI Planner21 CFR 892.5050Medical charged-particle radiation therapy systemRadiologyClass IIMUJ, QKB
Predicate Device	Device name: MRCAT BrainManufacturer: Philips Medical Systems MR Finland510(k) Clearance: K193109Classification Regulation: 21 CFR 892.5050Classification Name: Medical charged-particle radiation therapy systemClassification Panel: RadiologyDevice Class: IIProduct Code: MUJ
Reference Devices	Reference Device 1:Device name: MRCAT PelvisManufacturer: Philips Medical Systems MR Finland510(k) Clearance: K182888Classification Regulation: 21 CFR 892.5050Classification Name: Medical charged-particle radiation therapy systemClassification Panel: RadiologyDevice Class: IIProduct Code: MUJReference Device 2:Device name: Limbus ContourManufacturer: Limbus AI, Inc.510(k) Clearance: K201232Classification Regulation: 21 CFR 892.2050Classification Name: Medical image management and processing systemClassification Panel: RadiologyDevice Class: IIProduct Code: LLZ
Device Description Summary	The product MRI Planner is a stand-alone software providing informationto the treatment planning process prior to radiotherapy. Based on a DICOM
	MR image stack, the software generates synthetic CT images that can beused for attenuation calculations in radiotherapy treatment planning for thepelvis, brain and head-neck regions. In addition, the software alsogenerates contours of anatomical structures in the MR image stack, to beused as a starting point for the manual delineation work required inradiotherapy treatment planning. Contours are generated for prostate cancerpatients only (bladder, colon and femoral heads).MRI Planner utilizes pre-trained machine learning models to perform boththe conversion to synthetic CT and the automated structure contouring. Themodels for synthetic CT generation was trained using a dataset comprisingMR and CT images for 244 patients acquired in the treatment position atfour hospitals. The model for prostate cancer patient auto contouring wastrained using a dataset comprising MR images for 175 patients acquired inthe treatment position at four hospitals, together with in-house generatedexpert manual contours. MRI Planner does not display or store DICOMimages. The user is advised to use existing softwares for radiotherapytreatment planning to display and modify generated images and contours.
	MRI Planner runs on a standard x86-64 compatible system with a CUDAcapable NVIDIA GPU and requires Ubuntu Linux 18.04 operating system.
Indications For Use	MRI Planner is a software-only medical device intended for use by trainedradiation oncologists, dosimetrists and physicists to process images fromMRI systems to
	1) provide the operator with information of tissue properties for radiationattenuation estimation purposes in photon external beam radiotherapytreatment planning, and to
	2) derive contours for input to radiation treatment planning by assisting inlocalization and definition of healthy anatomical structures.
	MRI Planner is not intended to automatically contour tumors or tumorclinical target volumes.
	MRI Planner is indicated for radiotherapy planning of adult patients forprimary and metastatic cancers in the brain and head-neck regions, as wellas soft tissue cancers in the pelvis region.
	MRI Planner generates synthetic CT images for radiation attenuationestimation purposes for the pelvis, brain and head-neck regions only. MRIPlanner generates automatically derived contours of the bladder, colon andfemoral heads, for prostate cancer patients only.
Indications for Use comparison	MRI Planner provides the indications for use of the Predicate Device. ThePredicate Device has the intended use to provide the operator withinformation of tissue properties for radiation attenuation estimationpurposes in photon external beam radiotherapy treatment planning.
	MRI Planner includes the intended use of the Predicate Device, as itprovides the operator with information of tissue properties for radiationattenuation estimation purposes in photon external beam radiotherapytreatment planning. Additionally, it provides the functionality of autocontouring, which is not believed to raise additional safety concerns.
	As such, the indications for use of MRI Planner does not raise any
	additional or different concerns regarding safety or effectiveness ascompared to the Predicate Device.
Technological comparison	Both MRI Planner and the Predicate Device are machine learning based.Reference Device 1 was used as predicate device for the Predicate Deviceand is therefore also technologically equivalent. Both the Predicate Deviceand Reference Device 1 generates similar outputs as MRI Planner in theform of synthetic CT images. Since MRI Planner has similar technologicalcharacteristics as both the Predicate Device and Reference Device 1 withregard to synthetic CT generation, no differences in risk have beenidentified between the products.
	Both MRI Planner and Reference Device 2 use pre-trained machinelearning models to derive contours. Since MRI Planner has similartechnological characteristics as Reference Device 2 with regard to derivingcontours, no differences in risk have been identified between the products.
Summary of performancetesting	Dose accuracy bench test
	The conducted bench tests evaluate the dosimetric equivalence of MRIPlanner generated synthetic CT (sCT) and conventional CT. Dosimetricagreement was evaluated by comparing mean doses to target and non-targetvolumes as well as by means of gamma evaluation. The non-target sCT-CTdose difference was evaluated by computing the mean dose difference inall sub-volumes of the dose matrix not overlapping the target. Theacceptance criteria was that 99% of cases should have no sub-volumes withan sCT-CT dose difference in excess of 1.0 Gy or 5% of the CT-dose. Twovariations of gamma evaluation were conducted; one focusing on the highdose area (cut off at 75% of the maximum dose) and the other consideringalso the medium dose regions (cut off at 25% of the maximum dose). In thehigh dose gamma a 3%/3mm criteria was used for the pelvic and head-neckanatomical regions, while a 2%/2mm criteria was used for brain cases. Thegamma index passing rate requirement was 99% for pelvis and head-neck,and 98% for brain. In the medium dose range gamma evaluation the stricter2%/2mm criteria was used for all anatomical regions, while requiring a99% gamma index passing rate.
	The average sCT-CT mean target dose difference was found to be 0.02% ±0.31% and -0.02% ± 0.25% for the anatomical regions pelvis, and head-neck and brain, respectively. No cases displayed any sub-volumes withsCT-CT dose differences in excess of 5% or 1.0 Gy.
	At least 95% of cases met the passing criteria across all gamma evaluationsand anatomical regions. In the high dose gamma evaluation, 100.0% ofcases passed the individual passing rate criterion for all anatomical regions,while the average gamma index passing rate was 99.9%, 99.8% and 99.8%for pelvis, head neck and brain, respectively. In the medium dose gammaevaluation, 98.3% and 100.0% of cases passed the individual passing ratecriterion for pelvis, and head-neck and brain, respectively, while theaverage gamma index passing rate was 99.7%, 99.5% and 99.9% for pelvis,head neck and brain, respectively.
	Dosimetric bench test data for pelvis consisted of MR (T2w) and CTimages for 58 unique pelvis cancer patients acquired in the treatmentposition at six different hospitals. Patient distribution was 16% female and84% male, age range 51-88 years, 41% of patient images were acquired inthe US and 59% outside the US.
	Dosimetric bench test data for head-neck-brain consisted of MR (T1-Dixon) and CT images for 75 unique head-neck-brain cancer patientsacquired in the treatment position at four different hospitals. Patientdistribution was 39% female and 64% male, age range 41-85 years, 55% ofpatient images were acquired in the US and 45% outside the US.MRI data was acquired at six different MRI scanner models, from twodifferent vendors, with field strengths of 1.5T and 3T.
	Auto contouring bench test
	The conducted bench tests evaluates the automatically generated prostatepatient delineations (of bladder, colon and femoral heads) against manualdelineations, using two common metrics; Dice score (DSC) and 95%Hausdorff distance (HD).
	The average DSC was found to be 0.95 ± 0.03, 0.90 ± 0.04 and 0.96 ± 0.01for bladder, colon and femoral head delineations, respectively. The average95% HD was found to be 2.69 ± 1.82, 4.96 ± 3.91 and 2.04 ± 0.49 forbladder, colon and femoral head delineations, respectively.
	Auto contouring bench test data for prostate cancer patients consisted ofMR (T2w) images for 51 unique male prostate cancer patients acquired inthe treatment position at five different hospitals, together with manuallygenerated delineations of bladder, colon and femoral heads. Patient agerange was 51-88 years, 39% of patient images were acquired in the US and61% outside the US.
	Manual delineations were generated by two expert truthers using theconsensus approach, based on US clinical guidelines. The manualdelineations for the bench tests were generated at a separate time from thegeneration of the training dataset. The truthers were involved in thedevelopment of the product and the generation of the training dataset, butnot in the training and tuning of the segmentation model. Both trutherswere employed by the manufacturer at the time of performing the manualdelineations for the bench test.
Non-clinical test summary andconclusion	MRI Planner complies with the following international and FDA-recognized consensus standards:
	ISO 14971 Second edition 2007-03-01Medical devices – Application of risk management to medical devices
	IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION Medical device software - Software lifecycle processes
	IEC 62366-1:2015Medical devices - Part 1: Application of usability engineering to medicaldevices
	IEC 82304-1 Edition 1.0 2016-10Health software – Part 1: General requirements for product safety
	Non-clinical verification and validation tests have been performed

with regards to the intended use, the technical claims, the requirementspecifications and the risk management results. Non-clinical verificationand validation test results demonstrate that MRI Planner:Complies with the aforementioned international and FDA-recognized consensus standards Meets all acceptance criteria as described in the product testdescription and is adequate for its intended use.
In addition, non-clinical bench tests have been performed to investigate theperformance of MRI Planner against the Predicate Device. The bench testsdemonstrate that MRI Planner performs comparably to the PredicateDevice.
Taking all of the above into account, Spectronic Medical believes that MRIPlanner is as safe and effective as the Predicate Device, and is thereforesubstantially equivalent.

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Image /page/4/Picture/2 description: The image shows the logo for Spectronic Medical. The word "SPECTRONIC" is in large, bold, black letters with a black line underneath. Below the line, the word "MEDICAL" is in smaller, bold, black letters. There are three red diagonal lines above the word "SPECTRONIC".

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Image /page/5/Picture/2 description: The image shows the logo for Spectronic Medical. The word "SPECTRONIC" is in large, bold, black letters with a black line underneath. To the right of the word, there are three red diagonal lines, and below the right side of the word, the word "MEDICAL" is in smaller, black letters.

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Image /page/6/Picture/2 description: The image shows the logo for Spectronic Medical. The word "SPECTRONIC" is in large, bold, black letters. Above the word, there are three diagonal pink lines. Below the word, there are three diagonal black lines, and the word "MEDICAL" is in smaller, bold, black letters.

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Image /page/7/Picture/2 description: The image shows the logo for Spectronic Medical. The word "SPECTRONIC" is in large, bold, black letters. Above the word, there are three diagonal pink lines. Below the word, there are three diagonal black lines, and to the right of those lines is the word "MEDICAL" in smaller, bold, black letters.

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.