3DXR is the AW application which is intended to perform the three-dimensional (3D) reconstruction computation of any images acquired with a 3D Acquisition mode of the X-ray interventional system for visualization under Volume Viewer. The 3D Acquisition modes are intended for imaging vessels, bones and soft tissues as well as other internal body structures. The 3D reconstructed Volume assist the physician in diagnosis, surgical planning, Interventional procedures and treatment follow-up.

Device Description

3DXR is a post-processing software-only application, runs on Advantage Workstation (AW) platform [K110834], and performs 3D reconstruction for the CBCT 3D acquisition images (input) acquired from the fixed interventional X-ray system [K181403, K232344]. The reconstructed 3D volume (output) is visualized under Volume Viewer application [K041521]. The proposed 3DXR is a modification from the predicate 3DXR [included and cleared in K181403]. A new option, called CleaRecon DL, based on Deep-Learning (DL) technology, is added in the proposed subject 3DXR application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from Engineering Bench Testing)	Reported Device Performance
Quantitative (Image Analysis)
Reduction of Mean Absolute Error (MAE) between images with and without CleaRecon DL	A statistically significant reduction in MAE was observed between the two samples.
Increase of Structural Similarity Index Measure (SSIM) between images with and without CleaRecon DL	A statistically significant increase in SSIM was observed between the two samples.
Reduction of MAE (phantoms)	Reduction of MAE was observed.
Reduction of Standard Deviation (SD) (phantoms)	Reduction of SD was observed.
Qualitative (Clinical Evaluation)
CleaRecon DL removes streaks artifacts and does not introduce other artifacts	Clinicians confirmed that CleaRecon DL removes streaks artifacts and, in 489 reviews, did not identify any structure or pattern that has been hidden or artificially created by CleaRecon DL when compared to the original reconstruction.
CleaRecon DL provides a clearer image and impacts confidence in image interpretation	In 98% of the cases, the CBCT images reconstructed with CleaRecon DL option are evaluated as clearer than the conventional CBCT images. Clinicians assessed how it impacts their confidence in image interpretation. (Specific quantitative impact on confidence not provided, but generally positive due to clearer images.)
CleaRecon DL does not bring artificial structures and/or hide important anatomical structures	Within 489 reviews, clinicians did not identify any structure or pattern that has been hidden or artificially created by CleaRecon DL when compared to the original reconstruction.
No degradation of image quality or other concerns related to safety and performance (overall)	Engineering bench testing passed predefined acceptance criteria, demonstrated performance, and "no degradation of image quality, nor other concerns related to safety and performance were observed." Clinical evaluation results "met the predefined acceptance criteria and substantiated the performance claims."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Engineering Bench Testing:
- Test Set 1 (Image Pairs): Two samples (number not specified beyond "two samples").
- Test Set 2 (Phantoms): Not specified beyond "phantoms."
Clinical Image Quality Evaluation (Retrospective):
- Sample Size: 110 independent exams, each from a unique patient.
- Data Provenance: Retrospectively collected from 13 clinical sites.
  - 80 patients from the US
  - 26 patients from France
  - 4 patients from Japan
- Patient Population: Adult patients (pediatrics excluded) undergoing interventional procedures. No inclusion criteria for age (within adult range) or sex/gender (except for prostate).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Engineering Bench Testing: Not applicable; ground truth was intrinsic (images with and without applying CleaRecon DL, or phantoms with reference).
Clinical Image Quality Evaluation:
- Number of Experts: 13 clinicians.
- Qualifications: "Clinicians" (specific specialties or years of experience are not mentioned, but their role implies expertise in image interpretation for interventional procedures).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Clinical Image Quality Evaluation: Each of the 110 exams (with and without CleaRecon DL) was compared/evaluated at least 3 times independently by the recruited clinicians. This resulted in 490 pairs of clinicians' evaluations. This suggests a multi-reader, independent review with subsequent aggregation of results, rather than a formal consensus-based adjudication like 2+1 or 3+1 for individual cases, as the "489 reviews" and "98% of cases" suggest aggregated findings.

5. 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

A multi-reader multi-case (MRMC) study was implicitly conducted as part of the clinical image quality evaluation, with 13 clinicians reviewing 110 cases (though the "multi-case" aspect is strong, the "multi-reader" aspect is also present for each case, as each was reviewed at least 3 times independently).
Effect Size: The study focused on the impact of the image quality on interpretation, rather than a direct measure of human reader performance improvement in diagnostic accuracy or efficiency with and without AI assistance. The results indicated:
- "In 98% of the cases, the CBCT images reconstructed with CleaRecon DL option are evaluated as clearer than the conventional CBCT images."
- Clinicians were asked to assess "how it impacts their confidence in image interpretation," but the specific effect size or improvement in confidence wasn't quantified.
- No hidden or artificially created structures were identified, indicating perceived safety and reliability.
- Therefore, while it showed a significant improvement in perceived image clarity, it did not provide a quantitative effect size for human reader improvement (e.g., in AUC, sensitivity, or specificity) with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation of the algorithm was done as part of the "Engineering bench testing." This involved:
- Testing on a segregated test dataset of image pairs (with and without CleaRecon DL) where Mean Absolute Error (MAE) and Structural Similarity Index Measure (SSIM) were computed.
- Testing on phantoms where MAE and Standard Deviation (SD) were computed relative to a reference (without simulated artifacts).
- These tests directly assessed the algorithm's capability to reduce artifacts and improve image metrics without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Engineering Bench Testing:
- For the image pair comparison, the ground truth was essentially the "ideal" or "less artifact-laden" image derived from the paired comparison. This is a form of reference-based comparison where the output without the artifact or with the artifact corrected is the standard.
- For phantoms, the ground truth was the known characteristics of the phantom (e.g., absence of artifacts in the reference image).
Clinical Image Quality Evaluation:
- The ground truth was established through expert evaluation/consensus (13 clinicians evaluating side-by-side images). However, it was focused on subjective image quality and the presence/absence of artifacts, rather than ground truth for a specific diagnosis or outcome.

8. The sample size for the training set

The text states: "The CleaRecon DL algorithm was trained and qualified using pairs of images with and without streak artifacts." However, the specific sample size of the training set is not provided.

9. How the ground truth for the training set was established

The ground truth for the training set was established using "pairs of images with and without streak artifacts." This implies that for each image with streak artifacts, there was a corresponding reference image without such artifacts, which allowed the algorithm to learn how to remove them. The method by which these "pairs of images" and their respective "with/without streak artifacts" labels were generated or confirmed is not detailed. It could involve expert labeling, simulation, or other methods.

Summary

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February 25, 2025

GE Medical Systems SCS % Ning WEN Regulatory Affairs Program Manager 283 Rue De La Miniere BUC. 78530 FRANCE

Re: K243446

Trade/Device Name: 3DXR Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, QIH Dated: November 6, 2024 Received: January 24, 2025

Dear Ning WEN:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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)	K243446
Device Name	3DXR
Indications for Use (Describe)	3DXR is the AW application which is intended to perform the three-dimensional (3D) reconstruction computation of any images acquired with a 3D Acquisition mode of the X-ray interventional system for visualization under Volume Viewer. The 3D Acquisition modes are intended for imaging vessels, bones and soft tissues as well as other internal body structures. The 3D reconstructed Volume assist the physician in diagnosis, surgical planning, Interventional procedures and treatment follow-up.
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/4/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram in a circle on the left, followed by the text "GE HealthCare" on the right. The logo is purple in color and the text is in a sans-serif font.

K243446 510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92 the following summary of information is provided.

Date:	January 24, 2025
Submitter:	GE Medical Systems SCSEstablishment Registration Number - 9611343283, rue de la Minière78530 Buc, France
Primary Contact:	Ning WENRegulatory Affairs Program ManagerGE HealthCare, (GE Medical Systems SCS)Tel: +33 6 2324 6023Email: ning.wen@gehealthcare.com
Secondary Contact	Michelle HuettnerRegulatory Affairs DirectorTel: +1 901 558 8035Email: michelle.huettner@gehealthcare.com
Device Trade Name:	3DXR
Common/Usual Name:	3DXR, with CleaRecon DL option
Regulation Number:	21CFR 892.1650, Image-intensified fluoroscopic x-ray system
Primary Product Code:	OWB
Secondary Product Code:	QIH
Regulatory Class:	Class II
Predicate Device:
Device Name:	3DXR
Manufacturer:	GE Medical Systems SCS
510(k) number:	K181403
Regulation Number:	21CFR 892.1650, Image-intensified fluoroscopic x-ray system
Product Code:	OWB
Regulatory Class:	Class II

Device Description and Marketed Devices:

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The proposed 3DXR is a modification from the predicate 3DXR [included and cleared in K181403]. A new option, called CleaRecon DL, based on Deep-Learning (DL) technology, is added in the proposed subject 3DXR application. This new CleaRecon DL option triggered this subject 510(k) submission.

The proposed 3DXR with CleaRecon DL option addresses the same user needs as predicate 3DXR. The goal of CleaRecon DL option is to remove streak artifacts caused by the pulsatile nature of blood flow around contrasted objects such as contrast medium injected vessels and stent structures.

The primary features/functions of the proposed software are:

. 3D Reconstruction for the CBCT images.
. CleaRecon DL: powered by a Deep-Learning algorithm, ability to remove streak artifacts caused by the pulsatile nature of blood flow and appearing around contrasted objects such as contrast medium injected vessels and devices.
. 3DStent: ability to reconstruct coronary stent with the compensation of the respiratory and cardiac motion.
Ability to read Imaging Purposes information on CBCT images (containing the acquisition system 3D preset information).
Motion Freeze: ability to reduce the artifacts caused by involuntary respiratory motion.
Metal Artifact Reduction (MAR): ability to reduce the artifacts induced by the presence of metallic devices.
. Active Tracker Detection: allowing to localize and record Active Tracker position for future automatic registration of reconstructed volume with Ultrasound images.
. lodine Streaks Reduction: ability to reduce the streak artifacts induced by the high density of iodine.
Scatter Reduction: ability to reduce the scatter-induced non-uniformities.
Extended Range: allowing to increase the dynamic range of the 3D Volume.
CT Format: labeling the reconstructed 3D Volume with CT format.
Image Filters.
3D Volume Size selection.
3D Sub Volume selection.

Intended Use:

Indications for Use:

The 3D Acquisition modes are intended for imaging vessels, bones and soft tissues as well as other internal body structures.

The 3D reconstructed Volume assist the physician in diagnosis, surgical planning, Interventional procedures and treatment follow-up.

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Image /page/6/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple. The logo is clean and modern, conveying a sense of trust and innovation.

Technology:

The proposed device 3DXR employs the same fundamental scientific technology as its predicate device 3DXR [K181403].

In addition, the proposed device 3DXR includes an option CleaRecon DL powered by a Deep-Learning (DL) Convolutional Neural Network (CNN) for removing streak artifacts. The CleaRecon DL algorithm was trained and qualified using pairs of images with and without streak artifacts.

Device Modification Overview:

The table below summarizes the substantive feature/technological differences and similarities between the predicate device and the proposed device:

Specification	Predicate Device:3DXR [K181403]	Proposed Device:3DXR
Indications for Use	Identical	Identical
Patient Population	No limitations on the patientpopulation	Same, except for CleaRecon DLoption which is validated for adultpopulation only
3D Reconstruction	Yes	Yes
CleaRecon DL	No, streak artifacts reduction byIodine Streaks Reduction only	Yes, streak artifacts removalpowered by DL-based algorithm
3DStent	No, 3D reconstruction of movingobject with the compensation ofthe respiratory motion	Yes, 3D reconstruction of coronarystent with the compensation of therespiratory and cardiac motion
Imaging Purposes	No, read multiple acquisitionsystem DICOM tags to identifythe clinical protocol	Yes, read acquisition system 3Dpreset in Imaging Purposes DICOMtag
Motion Freeze	Identical	Identical
Metal Artifact Reduction	Identical	Identical
Active Tracker Detection	Identical	Identical
lodine Streaks Reduction	Identical	Identical
Scatter Reduction	Yes	Yes
Extended Range	Identical	Identical
CT Format	Identical	Identical
Image Filters	Yes	Yes
3D Volume Size selection	Identical	Identical
3D Sub Volume selection	Yes	Yes

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Image /page/7/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design with intertwined letters, and the text is in a simple, sans-serif font.

Determination of Substantial Equivalence:

Summary of Non-Clinical, Design Control Testing

The proposed device, 3DXR, has successfully completed the required design control testing per GE HealthCare Quality Management System. No additional hazards were identified, and no unexpected test results were observed. The proposed device complies with NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard. It was designed and manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485.

The following quality assurance measures were applied to the development of the device:

. Requirements Definition
. Risk Analysis
. Technical Design Reviews
. Formal Design Reviews
Software Development Lifecycle
. Performance testing (Verification, Validation)
. System Testing (Verification, Validation)

The proposed 3DXR has been successfully verified on the AW VolumeShare workstation [K110834] platform. All of the testing and results did not raise new or different questions of safety and effectiveness other than those already associated with the predicate device.

The substantial equivalence determination is also based on the software documentation for a BASIC level.

Additional Non-Clinical Testing

Engineering bench testing was used to demonstrate the performances of the new CleaRecon DL algorithm's capabilities to remove streak artifacts from CBCT reconstructions.

Performance was first tested on a segregated test dataset of image pairs (with and without applying CleaRecon DL for streak artifact correction), independent from the dataset for training of CleaRecon DL algorithm. Mean Absolute Error (MAE) and Structural Similarity Index Measure (SSIM) were computed for two samples. Acceptance criteria were reduction of MAE and increase of SSIM. A statistically significant reduction in MAE and increase in SSIM were observed between the two samples. It was thus concluded that the CleaRecon DL option reduces streak artifacts on tested images.

Performance was then tested on phantoms. CBCT images acquisitions made with the fixed interventional X-ray system [K181403, K232344] were performed with simulated streak artifacts conditions and without (reference). MAE with respect to the reference and standard deviation (SD) were computed to quantify streak artifact reduction. Acceptance criteria were reduction of MAE and SD. The reduction of both MAE and SD was observed leading to the conclusion that CleaRecon DL reduces streak artifacts on phantoms.

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Image /page/8/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple.

The engineering bench testing passed the predefined acceptance criteria, demonstrated the CleaRecon DL performance to remove streak artifacts, and no degradation of image quality, nor other concerns related to safety and performance were observed.

Summary of Clinical Testing

A retrospective clinical image quality evaluation was conducted to demonstrate the performances of the new CleaRecon DL algorithm's capabilities to remove streak artifacts from CBCT reconstructions and to ensure final validation of CleaRecon DL derived outputs.

110 independent exams (each from a unique patient) coming from 13 clinical sites were used in this evaluation, including:

Brain/Head: 20 patients Liver/Abdomen: 30 patients Prostate/Pelvic: 20 male patients Aorta/Stent-graft: 20 patients Other anatomies: 20 patients

These exams were retrospectively collected from the CBCT acquisitions performed with the fixed interventional X-ray system [K181403. K232344] on adult patients (pediatrics excluded) undergoing interventional procedures. 80 patients came from the US, 26 patients came from France, 4 patients came from Japan. These exams were anonymized. There were no inclusion criteria of age (within adult range) and sex/gender (except for prostate). These exams were independent and never used for the training and tuning of CleaRecon DL algorithm.

13 clinicians were recruited for this evaluation. Each of the 110 exams (with and without applying CleaRecon DL) was prepared so that the conventional reconstruction images and the images reconstructed with CleaRecon DL option were presented side by side on AW, with the same display conditions, and were compared / evaluated at least 3 times independently, resulting in 490 pairs of clinicians' evaluations.

For each image comparison, the physicians were asked (through 8 questions):

to evaluate the impact of CleaRecon DL on CBCT image quality, -
। to confirm that CleaRecon DL removes streaks artifacts and assess whether it brings other artifacts when compared to the conventional CBCT reconstruction.
to assess if CleaRecon DL provides a clearer image and how it impacts their confidence in image interpretation.
to assess if it brings artificial structures and/or hides important anatomical structures.

The evaluation results met the predefined acceptance criteria and substantiated the performance claims. In 98% of the cases, the CBCT images reconstructed with CleaRecon DL option are evaluated as clearer than the conventional CBCT images.

Within 489 reviews, clinicians did not identify any structure or pattern that has been hidden or artificially created by CleaRecon DL when compared to the original reconstruction.

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Image /page/9/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple. The overall design is clean and corporate, representing the brand identity of GE Healthcare.

Substantial Equivalence Conclusion

The changes to the predicate device 3DXR do not create new Intended Use nor Indication for Use. The proposed device 3DXR has identical or substantially equivalent technological characteristics as its predicate device.

GE HealthCare's quality system's design, verification, and risk management processes did not identify any new questions of safety or effectiveness, hazards, unexpected results, or adverse effects stemming from the changes to the predicate.

Based on the development under GE HealthCare's quality system, successful design verification and validation, software documentation for a "Basic" level, along with the engineering bench testing and the clinical evaluation by physicians demonstrate that the proposed 3DXR is substantially equivalent to, and hence as safe and as effective for its Intended Use as the legally marketed predicate device.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.