Agfa's Computed Radiography Systems with DX-G Digitizers are indicated for use in providing diagnostic quality images to aid the physician with diagnossis.

Systems can be used with either Musica or Musica 2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

System options and accessories are available for:

Pediatric imaging ●
Full leg/full spine .
Radiotherapy planning and QC .
Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or ● pediatric patients)
Musica2 Neonatal .

Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in mammography.

Device Description

The new devices are computed radiography imaging systems of similar design and construction to the predicates. The devices capture radiographic exposures on phosphor plates that are then scanned with a laser to create an electronic image. Electronic images can then be manipulated, printed, or sent to a softcopy capable display or archive such as a PACS system.

New DX-G digitizers provide the following new benefits:

The ability to use both standard and needle phosphor image plates with a single digitizer.
0 Input and output cassette storage buffers that allow the x-ray technologist to load up to five exposed cassettes at a time. The cassettes can be of any type and size, freeing the technologist from having to process and wait on each image separately.
. An image data format that provides slightly improved latitude for over-exposures.

The principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.

AI/ML Overview

The provided text describes a 510(k) summary for AGFA Computed Radiography (CR) Systems with DX-G Digitizers. It asserts substantial equivalence to a predicate device and mentions general testing, but it does not contain details about specific acceptance criteria or a dedicated study proving performance against such criteria.

Therefore, I cannot populate most of the requested fields definitively. Here's what I can extract or infer based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent diagnostic quality to predicate device	"Descriptive characteristics and performance data are adequate to ensure equivalence." (General statement, no specific metrics provided)
Proper performance to specifications	"Agfa's Computed Radiography (CR) Systems with DX-G Digitizers have been tested for proper performance to specifications through various internal tests." (No specific criteria or results provided)
Compliance with EN 60601-1-1 and EN 60601-1-2	"Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2." (No specific test results provided)
Maintenance of intended therapeutic/diagnostic effect	"Differences in devices do not alter the intended therapeutic/diagnostic effect." (General statement)
Ability to use both standard and needle phosphor image plates with a single digitizer	Implied by device description of new benefits. No specific test results.
0 Input and output cassette storage buffers allowing loading of up to five exposed cassettes	Implied by device description of new benefits. No specific test results.
Image data format providing slightly improved latitude for over-exposures	Implied by device description of new benefits. No specific test results.

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

Sample Size: Not specified.
Data Provenance: Not specified. The document mentions "various internal tests," which suggests company-generated data, but details like country of origin or whether it was retrospective/prospective are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document does not describe a study involving expert review for ground truth.

4. Adjudication method for the test set

Not specified. No such study is described.

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 study described. This device is a Computed Radiography system (hardware and associated basic image processing), not an AI-based diagnostic tool. Therefore, a study assessing human reader improvement with/without AI assistance would not be applicable or expected in this context.

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

No standalone algorithm performance study is described or applicable in the context of this device. This is a foundational imaging system, not an AI algorithm.

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

Not specified. Given the nature of a CR system, ground truth for image quality might be assessed through objective metrics (e.g., SNR, resolution, contrast), but no details are provided. Ground truth for diagnostic accuracy would typically involve comparison to an established clinical gold standard, which is not detailed here for any performance claim.

8. The sample size for the training set

Not applicable / Not specified. This device is an imaging system; the text does not describe an AI/machine learning component that would require a "training set" in the typical sense. Any internal image processing (like Musica/Musica2) would be based on algorithms, not necessarily a trained machine learning model from a distinct training set.

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

Not applicable / Not specified. As no training set is described for an AI/ML component, the method for establishing its ground truth is also not mentioned.

Summary

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K092238

510(K) SUMMARY AGFA COMPUTED RADIOGRAPHY (CR) SYSTEMS WITH DX-G DIGITIZERS

Common/Classification Name: Computed Radiography System, 21 CFR 892.1650 Proprietary Name: Computed Radiography (CR) Systems With DX-G Digitizers Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel AUG 1 1 2009 Belgium Contact: Jeffery A. Jedlicka, Prepared: July 13, 2009 Telephone: (864) 421-1815 Facsimile: (864) 421-1635

A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for Agfa's Computed Radiography Systems with DX-G Digitizers. The predicate devices are Agfa's Computed Radiography Systems with NX Workstations (K090672).

B. DEVICE DESCRIPTION

New DX-G digitizers provide the following new benefits:

The ability to use both standard and needle phosphor image plates with a single digitizer.
0 Input and output cassette storage buffers that allow the x-ray technologist to load up to five exposed cassettes at a time. The cassettes can be of any type and size, freeing the technologist from having to process and wait on each image separately.
. An image data format that provides slightly improved latitude for over-exposures.

The principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.

C. INTENDED USE

Agfa's Computed Radiography Systems with DX-G Digitizers have the same intended use as the predicate devices:

They are intended for use in providing diagnostic quality images to aid the physician with diagnosis.

Systems can be used with either Musica or Musica2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

System options and accessories are available for:

Pediatric imaging .
Full leg/full spine ●
. Radiotherapy planning and QC
Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric . patients)
Musica2 Neonatal .

In the USA, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.

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SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's Computed Radiography (CR) Systems with DX-G Digitizers have the same indications for use statement as the legally marketed predicate devices (those with NX software). The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in devices do not alter the intended therapeutic/diagnostic effect.

TECHNOLOGICAL CHARACTERISTICS E.

The technological characteristics are the same in the proposed and predicate devices. Both the predicate and new devices use x-rays received by photostimulable plates to create latent diagnostic images. Plates are then scanned by a laser which converts the images into a digital form that can be previewed, adjusted if necessary, then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.

TESTING F.

Agfa's Computed Radiography (CR) Systems with DX-G Digitizers have been tested for proper performance to specifications through various internal tests. Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2.

CONCLUSIONS G.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features an image of a caduceus, a symbol of medicine, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AGFA Healthcare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

AUG 2 3 2013

Re: K092238

Trade/Device Name: Computed Radiography (CR) Systems with DX-G Digitizers Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 22, 2009 Received: July 23, 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of August 11, 2009.

We have reviewed vour 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

092239 510(k) Number (if known):

Device Name: Computed Radiography (CR) Systems with DX-G Digitizers

Indications for Use:

Agfa's Computed Radiography Systems with DX-G Digitizers are indicated for use in providing diagnostic quality images to aid the physician with diagnossis.

Systems can be used with either Musica or Musica 2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

System options and accessories are available for:

Pediatric imaging ●
Full leg/full spine .
Radiotherapy planning and QC .
Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or ● pediatric patients)
Musica2 Neonatal .

Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in mammography.

Prescription Use X	AND/OR	Over-The-Counter Use ______
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092238

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.