AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

• K Number: K231709
• Device Name: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
• Manufacturer: Radmedix LLC
• Date Cleared: 2023-07-12 ( 30 days)
• Product Code: MQB ACU LLZ
• Regulation Number: 892.1680

Intended Use

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Device Description

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configurations for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the Acculvue software cleared in our predicate K210919.

Predicate Devices

K210919

Reference Devices

K210314, K210316, K220668

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a digital x-ray system upgrade kit that incorporates previously cleared digital panels and software. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the image quality and technical specifications of the digital panels.

Therapeutic

No.
The device is intended for taking diagnostic x-rays, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays." This directly indicates its use for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes both software and digital radiography panels, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
• Device Function: The description clearly states that this device is a "complete digital x-ray system upgrade kit" used for "taking diagnostic x-rays." X-rays are an imaging modality that uses radiation to create images of the inside of the body, not by analyzing biological specimens.
• Intended Use: The intended use is for "taking diagnostic x-rays," which is a form of medical imaging, not in vitro testing.
• Components: The components listed are related to an x-ray system (digital radiography panels, software, x-ray generator, tubehead, collimator), not equipment for analyzing biological samples.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Product codes (comma separated list FDA assigned to the subject device)

MQB, LLZ

Device Description

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configurations for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the Acculvue software cleared in our predicate K210919.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric subjects

Intended User / Care Setting

qualified/trained physician or technician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical image evaluation was performed on the proposed panels by a Board Certified Radiologist. The images were found to be of excellent quality.
Performance characteristics are as follows:
AcuityDR 1013 G4: DQE@ 1.0 lp/mm:0.51; MTF @ 2.0 lp/mm: 0.38
AcuityDR 1417 G4: DQE@ 1.0 lp/mm:0.55; MTF @ 2.0 lp/mm: 0.40
AcuityDR 1717 G4 : DQE@ 1.0 lp/mm:0.55; MTF @ 2.0 lp/mm: 0.40

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K210919

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K210314, K210316, K220668

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Summary

0

July 12, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Radmedix LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114

Re: K231709

Trade/Device Name: AcuityDR G4 (AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, LLZ Dated: June 12, 2023 Received: June 12, 2023

Dear Daniel Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

2

Indications for Use

510(k) Number (if known) K231709

Device Name AcuityDR G4 (AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4)

Indications for Use (Describe)

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

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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510(k) Summary K231709

Image /page/3/Picture/1 description: The image shows a logo with the text "RadmediX". The "R" and "X" are in blue, while the "admedi" is in a smaller font size and in black. There is a larger, faded "RX" in the background, behind the main text. The logo is simple and modern, with a focus on the company name.

RadmediX, LLC 2510 Lance Rd. Dayton, OH 45409 Tel: [phone] Registration Number: 3009134655

1. Administrative Information

Reason for Submission: 510(k) Notification for AcuityDR G4 Submitter Submission contact person: Gabriel Issa, Director of Equipment Contact e-mail: [e-mail] Date prepared: June 9, 2023

ldentification:

Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

AcuityDR G4 (AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4) Stationary X-Ray System Radiology 21 CFR §892.1680 Class II MQB, LLZ

Substantially equivalent device:

Trade Name:	AcuityDRe
Manufacturer:	RadmediX
510(k) #:	K210919
Classification Name:	Stationary x-ray system
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	MQB, LLZ

Reference devices:

K210314
Trade/Device Name:	Mars1717X Wireless Digital Flat Panel Detector
Regulation Number:	21 CFR 892.1680
Regulation Name:	Stationary x-ray system
Regulatory Class:	Class II
Product Code:	MQB

K210316

Trade/Device Name:	Mars 1417X Wireless Digital Flat Panel Detecto
Regulation Number:	21 CFR 892.1680
Regulation Name:	Stationary x-ray system
Regulatory Class:	Class II
Product Code:	MQB

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K220668
Trade/Device Name:	Wireless Digital Flat Panel Detector
Regulation Number:	21 CFR 892.1680
Regulation Name:	Stationary X-Ray System
Regulatory Class:	Class II
Product Code:	MQB

• 2. Device description: AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configurations for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the Acculvue software cleared in our predicate K210919.
• 3. Indications for Use: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

| Comparable
Properties | AcuityDRe, K210919 | AcuityDR G4 | Comparison
Results |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Indications for
use | Intended for use by a
qualified/trained physician or
technician on both adult and pediatric
subjects for taking diagnostic x-rays.
Not for mammography. | Intended for use by a
qualified/trained physician or
technician on both adult and pediatric
subjects for taking diagnostic x-rays.
Not for mammography. | SAME |
| X-ray Generator | Supplied by User: CPI or Sedecal | Supplied by User: CPI or Sedecal | SAME |
| Software Control
of Technique
Factor | Possible for certain CPI or Sedecal
Generators (Validated previously). See
below. | Possible for certain CPI or Sedecal
Generators (Validated previously). See
below. | SAME |
| Digital X-Ray
Detectors | AcuityDRe 1417w
AcuityDRe 1717w
AcuityDRe 1717t | AcuityDR 1013 G4
AcuityDR 1417 G4
AcuityDR 1717 G4 | SAME |
| Panel
Performance | AcuityDRe 1417w: DQE@ 1.0 lp/mm: 35%; MTF @ 2.0 lp/mm: 31% | AcuityDR 1013 G4: DQE@ 1.0 lp/mm: 51%; MTF @ 2.0 lp/mm: 38% | Similar but better
results |
| | AcuityDRe 1717w/1717t: DQE@ 1.0 lp/mm: 42%; MTF@ 2.0 lp/mm: 38% | AcuityDR 1417 G4: DQE@ 1.0 lp/mm: 55.9%; MTF @ 2.0 lp/mm: 40.4%
AcuityDR 1717 G4: DQE@ 1.0 lp/mm: 55.9%; MTF @ 2.0 lp/mm: 40.4% | |

4. Technological characteristics: Comparison Table

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| Comparable
Properties | AcuityDRe, K210919 | AcuityDR G4 | Comparison
Results |
|--------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------|
| Panel Sizes | AcuityDRe 1417w 148 µm
AcuityDRe 1717w 140 µm
AcuityDRe 1717t 140 µm | AcuityDR 1013 G4 100 µm
AcuityDR 1417 G4 100 μm
AcuityDR 1717 G4 100 µm | Similar but higher
resolution |
| Operator console | Windows PC using Windows 10-loT | Windows PC using Windows 10-loT | SAME. |
| Acquisition
Software | AccuVue | AccuVue | SAME. |
| Power Source | AC Line or rechargeable batteries
(wireless models) | AC Line or rechargeable batteries (all
models) | SAME. |
| Standards | Same as below | Same as below | SAME. |

5. Non clinical testing: Testing was performed according to the following standards:

| FDA
Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number And Date | Title Of Standard |
|------------------------------|----------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | IEC | 60601-
1:2005/(R)2012
And Al:2012 | Medical Electrical Equipment Part 1: General Requirements
For Basic Safety And Essential Performance (IEC 606011:2005,
MOD) |
| 19-8 | IEC | 60601-1-2:2014 | Medical Electrical Equipment Part 12: General Requirements
For Basic Safety And Essential Performance Collateral Standard:
Electromagnetic Disturbances Requirements And Tests |
| 12-342 | NEMA | PS 3.1 - 3.20
(2021e) | NEMA Digital Imaging and Communications in Medicine
(DICOM) Set |

• 6. The digital panel software employed was used unmodified from clearance obtained from FDA. The software has previously been validated as a control for CPI and Sedecal diagnostic x-ray generators. Compatible CPI generators: CMP 200 Series. Compatible Sedecal generators: SFHR and SHF Series. In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals. In recognition of FDA pediatric concerns, we reviewed the FDA guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff and created labeling to comply with this guidance. In recognition of FDA's concerns about wireless performance we reviewed the FDA guidance: Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff. Both the predicate and subject devices use the same wireless technology, standard Wi-Fi using FCC approved off the shelf components. Since three new digital receptor panels have had previous FDA clearance, imaging performance testing had previously been performed. Clinical image evaluation was performed on the proposed panels by a Board Certified Radiologist. The images were found to be of excellent quality.
     Performance characteristics are as follows:

AcuityDR 1013 G4: DQE@ 1.0 lp/mm:0.51; MTF @ 2.0 lp/mm: 0.38

AcuityDR 1417 G4: DQE@ 1.0 lp/mm:0.55; MTF @ 2.0 lp/mm: 0.40

AcuityDR 1717 G4 : DQE@ 1.0 lp/mm:0.55; MTF @ 2.0 lp/mm: 0.40

All proposed compatible generators carry NRTL listing labels, having been tested for safety. Validation of proper generator technique control had been previously performed. Each system is tested for proper integration prior to shipment to the customer. Since multiple configurations are available (generator and panel models), our service engineers fully test each new system upon installation at the customer site

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• 7 . Clinical testing. Not required for a determination of substantial equivalence.
• 8. Substantial Equivalence Discussion. When combined with a compatible generator/Tubestand combination the AcuityDR G4 performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images. In all material aspects, the AcuityDRe systems and the AcuityDR G4 systems are substantially equivalent to each other.

9. Substantial Equivalence Conclusion:

After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of RadmediX LLC that the AcuityDR G4 series of upgrade kits are as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.