The ANY VIEW DR SERIES (Anyviw-500DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

Device Description

The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) are mobile x-ray fluoroscopic imaging systems used by radiation experts. ANYVIEW DR SERIES are a digital fluoroscopic imaging systems with Flat Panel Detector (FPD) used in diagnostic and interventional procedures. ANYVIEW DR SERIES are composed of C-arm, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motor-type collimator), FPD, and workstation (console computer and monitor).

ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, ANYVIEW FPD Fluoroscopic Mobile X-ray System. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from ANYVIEW DR SERIES FPD Fluoroscopic Mobile X-ray System.

ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm imaqes taken during an exam are stored in the database for further review. I Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system.

AI/ML Overview

The ECOTRON Co., Ltd. ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm (ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR) is a radiation medical equipment designed to provide fluoroscopic and spot film images for diagnostic and interventional procedures. The device was found to be substantially equivalent to its predicate device, Anyview-500R Fluoroscopic Mobile X-ray System (K160279), based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state formal "acceptance criteria" in a go/no-go format for performance metrics. Instead, it presents a comparison of technical characteristics and performance data of the subject device against its predicate and reference devices, demonstrating equivalent or improved performance without raising new safety or effectiveness concerns.

Characteristic	Acceptance Criteria (Implied by Predicate/Reference)	Subject Device Performance (ANYVIEW DR SERIES)	Predicate Device Performance (Anyview-500R, K160279)	Reference Device Performance (D2RS AT, K150306)
Intended Use	Fluoroscopic and spot film images for diagnostic and interventional procedures.	Same	Same	N/A (Reference device details less explicit for this)
Energy Source	220V~230V, Single 50/60 Hz	Same	Same	N/A
X-ray Generator Type	HFG INVERTER TYPE	Similar (HFG INVERTER TYPE)	HFG INVERTER TYPE	N/A
Fluoroscopy Continuous Mode	0.5-10mA	Same	Same	N/A
Fluoroscopy Pulsed Mode	0.5-20mA	Same	Same	N/A
Fluoroscopy Boost Mode	30mA	Same	Same	N/A
Radiography kV Range	40-125 kV	Similar (40-125 kV depending on model)	40-125 kV	N/A
Radiography mA Range	20-100 mA	Similar (15-100 mA depending on model)	20-100 mA	N/A
Radiography mAs Range	0.8-200 mAs	Similar (0.8-200 mAs depending on model)	0.8-200 mAs	N/A
X-ray Tube Type	TOSHIBA XR-2551	TOSHIBA XRR-2251 (Same)	TOSHIBA XR-2551	N/A
Detector Type	Image Intensifier (Predicate) / Flat Panel Detector (Reference)	Flat Panel: TFT: a-Si w/CsI: TI scintillator	Imaging Intensifier: E5830SD-P4A	Pixium RF 4343 (FPD)
Detector Input FOV	9 inch (Predicate)	12 x 12 in	9 inch	17x17 in
Detector Central Resolution	54/62/70 lp/cm (Predicate)	3.4 lp/mm	54/62/70 lp/cm (for 9/6/4.5 inch modes)	3.4 lp/mm
Detector MTF (1 lp/mm)	N/A (Predicate, different detector type)	54% (VS VIeworks), 60% (VS Thalaes)	N/A	62%
Detector DQE (1 lp/mm)	65% (Predicate)	69% (VS VIeworks), 69% (VS Thalaes)	65%	52%
Detector Spatial Resolution	5.2 lp/mm (Predicate)	3.4 lp/mm	5.2 lp/mm (min)	3.4 lp/mm
Pixel Size/Output Resolution	1K x 1K (Predicate - implied)	2K x 2K	1K x 1K (implied from 12bit grayscale)	N/A (implied by 2874x2840 pixels)
Electrical Safety Standards	IEC 60601-1, -1-2, -1-3, -2-28, -2-43, -2-54	Meets all listed IEC standards	Meets all listed IEC standards	N/A
EPRC Performance Standard	21 CFR 1020.30/1020.32	Meets 21CFR 1020.30/1020.32	Meets 21CFR 1020.30/1020.32	N/A

2. Sample size used for the test set and the data provenance:

Test Set: The study primarily relies on bench testing and comparative performance data of components (specifically the Flat Panel Detector, FPD) for non-clinical evaluation. There is no mention of a traditional "test set" of patient images.
Data Provenance: The data provenance for the performance characteristics (MTF, DQE, Spatial Resolution) of the detectors is from the respective manufacturers (VIEWORKS for Subject Device, TOSHIBA for Predicate Device, and Thales for Reference Device). This is non-clinical, technical performance data. The document does not specify country of origin for this component-level data, nor whether it is retrospective or prospective, though it is typically collected during product development/testing by the manufacturer.

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):

Not applicable. The study is a 510(k) submission for substantial equivalence based on technical and performance characteristics of medical hardware, not on clinical image interpretation or diagnostic accuracy by experts. No ground truth was established by human experts for a test set of images.

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

Not applicable, as no test set requiring expert adjudication was used.

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:

No MRMC comparative effectiveness study was done. The device described is an X-ray imaging system, not an AI-powered image analysis tool.

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

Not applicable. The device is an imaging system, not an algorithm, and its performance evaluation does not involve standalone algorithm assessment.

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

Not applicable. The equivalence is established through engineering and technical performance comparisons of the device and its key components against predicate and reference devices, not against clinical ground truth. Performance metrics like MTF, DQE, and spatial resolution are derived from physical measurements and scientific testing of the imaging system and its components.

8. The sample size for the training set:

Not applicable. This is a medical device for imaging acquisition, not a machine learning or AI algorithm, so there is no concept of a "training set."

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 23, 2018

ECOTRON Co., Ltd. % Mr. Dave Kim President Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K180473

Trade/Device Name: ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA, OXO Dated: February 15, 2018 Received: February 22, 2018

Dear Mr. Kim:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Mr. Dave Kim

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Michael D. O'Hara For

Robert 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) K180473

Device Name ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

Indications for Use (Describe)

This system can be applied in emergency room, operation room, cast room or etc. of hospital

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 is a logo for "eco & electronics eddotron". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black and is above the word "eddotron", which is in a gray color.

SECTION 07

510(k) SUMMARY

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1. Traditional 510(k) SUMMARY

This summary of 510(k) is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.

Date 510K summary prepared : February 15, 2018

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	ECOTRON Co, Ltd.
Submitter's Address:	Rm 504, Hanshin IT Tower II, 47, Digital-ro 9-gil,Geumcheon-gu, Seoul, Korea
Submitter's Telephone:	Tel:+82-2-2025-3760 / Fax:+82-2-2025-3764
Contact person:	Mr. Sang Bong Lee / RA Assist Mgr
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

510K Number:
Trade/proprietary name:	ANYVIEW DR SERIES
	FPD Fluoroscopic Mobile C-Arm
Model Number:	ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
Regulation Name:	Interventional Fluoroscopic Mobile X-ray System
Regulation Number:	21 CFR 892. 1650
Regulatory Class:	Class II
Product Code:	OWB, JAA, OXO
Predicate Device
Trade Name	ANYVIEW-500R Fluoroscopic Mobile X-ray System
510(k) Clearance #	K160279
Clearance date	10/14/2016
Classification Name	Image Intensified Fluoroscopic X-ray System
Classification Panel	Radiology
CFR Section	21CFR 892.1650 (Produce Code; OWB, JAA, OXO)
Device Class	Class II

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Reference Device

Trade Name
510(k) Clearance #
Clearance date
Classification Name
Classification Panel
CFR Section
Device Class

D2RS AT Digital Dynamic Remote System K150306 10/10/2015 Image Intensified Fluoroscopic X-ray System Radiology 21CFR 892.1650 (Produce Code; JAA) Class II

2. Device Description

3. Indications for Use

The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

4. Summary of Design Control Risk management

ANYVIEW DR SERIES FPD Fluoroscopic Mobile X-ray System has been developed to provide the mobility of X-ray users for convenient access to patients while meeting the

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critical functional requirements and international safety standards. The risks and the hazardous impact of the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design and production were successfully mitigated and accepted.

5. Summary of the technological characteristics of the device compared to the predicate device:

The indications for use and technical characteristics of ANYVIEW DR SERIES FPD Fluoroscopic system described in the 510(k) summary are similar to those of the predicate device, Anyview-500R Fluoroscopic Mobile X-ray System (K160279). Other than the digital flat panel detector, the ANYVIEW DR SERIES, the subject device, uses the same hardware, and same Anyview imaging software used for the predicate device (K160279). The difference is that the subject device is equipped with VIVIX-D 1212G digital detector whereas the predicate device is using imaging intensifier for imaging acquisition. In addition, ANYVIEW DR SERIES Fluoroscopic system offers lower power output compared to the predicate device.

6. Substantial Equivalence

ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to electro-, mechanical-, software-, clinical-, and risk management, it's the sponsor's opinion that the subject device is a safe and effective device.

Characteristics	Anyview FPD Fluoroscopic Mobile X-ray System	Anyview-500R Fluoroscopic Mobile X-ray System (K160279)	SE-#
Intended Use	The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during	Anyview-500R mobile C-arm, fluoroscopic x-ray system, is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic	Same
	diagnosticandinterventional procedures.	andinterventional procedures.
	This system can beapplied in emergencyroom, operation room,cast room or etc. ofhospital.	This system can beapplied in emergencyroom, operation room,cast room or etc. ofhospital.
Energy Source	220V~230V,Single 50/60 Hz	220V~230V,Single 50/60 Hz	Same
X-rayGeneratorType	HFG INVERTER TYPE	HFG INVERTER TYPE	Similar
Output power	Anyview-240DR 2.4 kWAnyview-320DR 3.2 kWAnyview-500DR 5.0 kW	5kW	#1
Fluoroscopy
-Continuousmode	0.5-10mA	0.5-10mA	Same
-Pulsed mode	0.5-20mA	0.5-20mA	Same
-Boost mode	30mA	30mA	Same
Radiographymode
-kV range	Anyview-240DR 40-110Anyview-320DR 40-110Anyview-500DR 40-125	40-125 kV	Similar#2
-mA range	Anyview-240DR 16-30Anyview-320DR 15-40Anyview-500DR 20-100	20-100 mA	Similar#2
-mAs range	Anyview-240DR 0.8-100Anyview-320DR 0.8-100Anyview-500DR 0.8-200	0.8~200mAs	Similar#2
X-ray tubetype	TOSHIBA XRR-2251	TOSHIBA XR-2551	Same
Max kV	125kV	125kV	Same
Focal spot (S/L)	0.3 / 0.6	0.3 / 0.6	Same
Target angle	10°	10°	Same
Anode heatcapacity	210 KHU	210 KHU	Same
Collimator	Open/close motorized	Open/close motorized	Same

type
Rotation	360°	360 °	Same
Detector	Flat Panel: TFT: a-Si w/CsI: TI scintillator	ImagingIntensifier:E5830SD-P4A (TOSHIBA)	#3
Input FOV	12 x 12 in	9inch	Similar
Centralresolution	3.4 lp/mm	*54/62/70 lp/cm	#4
Laser Pointer	Included	Included
(1) Laser Class	Class II	Class II
(2) Max Power	5mW	5mW	Same
(3) Wavelength	655nM	655nM	Same
Viewing SW	ANYVIEW imagingsoftware	ANYVIEW imagingsoftware (K160279)	Same
PerformanceStandard	21CFR 1020.30/1020.32	21CFR 1020.30/1020.32	Same
Electrical Safety	IEC 60601-1:IEC 60601-1-2IEC 60601-1-3IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54	IEC 60601-1:IEC 60601-1-2IEC 60601-1-3IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54	Same

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Image /page/7/Picture/0 description: The image contains the logo for "ecoTRON eco & electronics". The logo features the word "ecoTRON" in a bold, sans-serif font, with "eco" in blue and "TRON" in gray. Above "ecoTRON" is the text "eco & electronics" in a smaller, sans-serif font. To the left of "ecoTRON" are three blue squares.

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Image /page/8/Picture/0 description: The image shows the logo for "eco & electronics edOTRON". The logo has three blue squares on the left side, followed by the word "edOTRON" in grey. Above the word "edOTRON" is the text "eco & electronics" in black. The logo is simple and modern, and the colors are clean and professional.

Note *: Anyview-500R imaging intensifier (K160279) has different entrance field sizes; 9/6/4.5 inch. Therefore, the central resolution for each entrance field size is different; 54/62/70 lp/cm, respectively

SSXI Performance Comparison Data (#5)

	Subject Device	Predicate device (Anyview-500R)
Model Name	VIVIX-D 1212G	E5830SD-P4A (previously cleared under K160065)
Manufacturer	VIEWORKS	TOSHIBA
Size	12 x 12 in (2048x2048 pixels)	9 in (230mm min)
MTF	54 % @ 1 lp/mm
DQE	69 % @ 1 lp/mm	65 %
Spatial resolution	3.4 lp/mm	5.2 lp/mm

SSXI Performance Comparison Data (#6)

	Subject Device	Reference Device(D2 RS_AT Digital DynamicRemote System)
--	----------------	-----------------------------------------------------------------

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Model Name	VIVIX-D 1212G	Pixium RF 4343 (K150306)
Manufacturer	VIEWORKS	Thalaes
Size	12 x 12 in (2048x2048 pixels)	17x17 in (2874x2840 pixels)
MTF	60% @ 1 lp/mm,28%@2lp/mm	62% @ 1 lp/mm, 25%@2 lp/mm)
DQE	69%@ 1 lp/mm, 44%@ 2lp/mm	52% @ 1 lp/mm, 42%@2 lp/mm)
Spatial resolution	3.4 lp/mm	3.4 lp/mm

7. Difference Discussion

SE-#	SE discussion
SE-#1, #2,#3,#4	#1, #2:Both the subject device and predicate device have the same generator.Therefore, the output power ranges (kV, mA, mAs) are the same for thesubject and predicate device. The maximum output power for differentmodels of the subject device can be limited by software setting.
	#3, #4, #5, #6The predicate device (Anyview-500R) is equipped with Image Intensifier.Anyview-500DR, the subject device, is equipped with a FPD whichconverts charging level of receiving light element to AD for output on amonitor. It reduces distortions during the data conversion. Thegrayscale per pixel of Image Intensifier after digital data conversion is12bit (4096 step) whereas the grayscale of FPD is 16bit (65536 step). Ahigher grayscale can express X-ray image better and more details. Inaddition, the output resolution of the subject device is 4 times higher thanthe predicate device; 2K x 2K and 1K x 1K, respectively.
	The VIVIX-D 1212G FPD for the subject device is compared to Pixium RF4343, FPD equipped for the reference device. Each FPD for the subjectdevice and the reference device has the same spatial resolution of 3.4lp/mm and demonstrates equivalent bench test performance in terms ofMTF and DQE.

8. Summary of the technological characteristics of the device compared to the predicate device:

The indications for use, operating principle, and technical characteristics of the subject device described in this 510k are similar to those of the predicate device. The specifications of X-ray tube, X-ray generator, and X-ray tube anode heat content (Heating Unit) of the subject device are identical to those of the predicate device.

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Image /page/10/Picture/0 description: The image shows the logo for "eco & electronics edotron". The "eco" part is in a smaller font and is above the word "edotron". The "edo" part of "edotron" is in blue, while the "tron" part is in gray. To the left of the word "edo" are three blue squares.

The primary difference is that the subject device is equipped with a flat panel detector whereas the predicate device uses image intensifier.

MTF, DQE and spatial resolution for each detector type have been studied for comparison between the subject and predicate device. The bench testing demonstrated equivalent performance between the subject and predicate device.

The pixel size (2k x 2k) of the subject device is better than the active pixel (1K x 1K) of the predicate device.

These differences do not have significant effect on safety and effectiveness compared to the predicate device.

ANYVIEW imaging software of the subject device and the predicate device is identical.

9. Description of non-clinical tests.

The subject device has been tested for electrical safety and electromagnetic compatibility. The device also complies with FDA EPRC Performance Standard: 21 CFR 1020.30-32. The software validation and verification testing was also performed. The results of nonclinical testing indicate that the subject device is as safe and effective as Anyview-500R Fluoroscopic Mobile X-ray System, the predicate device.

Compliance evidences were submitted for the following standards:

IEC60601-1:2005 + A1 (2012)
IEC60601-1-2:2014
IEC60601-1-3:2008
IEC60601-2-28:2010
IEC60601-2-43:2010
IEC60601-2-54:2009
NEMA PS 3.1-3.20

The subject device meets EPRC requlation requirements.

21CFR1020.30
21CFR1020.32

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10. Description of clinical tests.

No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness.

11. Conclusion as to Substantial Equivalence

The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR), the subject device are substantially equivalent to the predicate (K160279). The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate device. Some characteristics, for example, their appearance, the user interfaces and the detector's performance are different. However, the performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the sponsor's opinion that the subject device appears to be as safe and effective as the 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.