CANON X-RAY DIGITAL CAMERA CXDI-22 provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Device Description

The Canon X-ray digital camera model CXDI-22 is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

AI/ML Overview

The provided 510(k) summary for the Canon CXDI-22 X-ray Digital Camera focuses on establishing substantial equivalence to a predicate device (Canon CXDI-11) rather than presenting a performance study with specific acceptance criteria and detailed results.

Therefore, much of the requested information regarding specific acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document primarily details the hardware specifications and intended use of the device and its predicate.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria (Not Explicitly Stated as AC, but implied by predicate comparison)	Reported Device Performance (CXDI-22)	Basis (from comparison table)
Intended Use	Provide diagnostic images for general radiography, replacing film/screen systems.	Provide diagnostic images for general radiography with table system. Intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.	Same as predicate (CXDI-11) for diagnostic imaging purposes
Design	Digital acquisition, electronic processing.	Same	Same as predicate
Energy Usage	Receives x-radiation generated by external x-ray generator.	Same	Same as predicate
X-ray Absorber	Fluorescent screen ($Gd_2O_2S:TB^{3+}$), Visible emission peak: 545nm.	Same	Same as predicate
Sensing Means	Amorphous Silicon W/TFT Array, Detection peak: 540-620nm.	Same	Same as predicate
Anatomical Sites	General radiography.	Same	Same as predicate
Target Population	General population.	Same	Same as predicate
Physical Safety	Minimize exposure to x-radiation.	Same	Same as predicate
Compliance	Complies with IEC 601-1-2.	Same	Same as predicate
Biocompatibility	N/A.	N/A	Same as predicate
Performance	After digital processing (optimize the gray-scale).	Same	Same as predicate
MTF@2lp/mm	42% (for CXDI-11). Implied acceptance criterion would be >= 42%.	42%	Same as predicate
Dynamic Range	Approximately 4 digit (linear A/D : 14bit), output data : 12bit.	Same	Same as predicate
Key Difference	N/A (CXDI-11 operates with upright stand).	Retrofit kit for installation into an existing radiologic table.	Specific difference between the two models

Note on Acceptance Criteria: The document implies that the CXDI-22 meets "acceptance criteria" by demonstrating that its technical characteristics are "Same" as the predicate device (CXDI-11) or by detailing the specific physical changes (e.g., sensor unit dimensions, power supply, table integration) without indicating any degradation in core imaging performance metrics like MTF or Dynamic Range. The performance metrics listed for CXDI-11 are implicitly the acceptance criteria for CXDI-22 for substantial equivalence.

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

Not available. The document does not describe a performance study with a specific test set. The submission is based on comparison to a predicate device.

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

Not available. As there is no described test set or performance study, there is no mention of experts establishing ground truth.

4. Adjudication method for the test set:

Not available.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The document does not describe an MRMC comparative effectiveness study.

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

Yes, implicitly. The device itself is an image capture system; its performance metrics (MTF, dynamic range) are inherent to the hardware and are evaluated as "standalone" technical specifications rather than in a human-in-the-loop context for this type of 510(k) submission. However, a formal "standalone study" report is not provided. The comparison chart indicates that the CXDI-22 shares the "Same" performance characteristics as the predicate CXDI-11, which would have undergone similar standalone technical evaluations.

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

Not applicable / Not available. For demonstrating substantial equivalence for an X-ray digital camera, the "ground truth" often refers to physical measurements of image quality (e.g., MTF, DQE) rather than clinical diagnostic accuracy against pathology or outcomes. The provided document relies on demonstrating equivalent technical specifications to a previously cleared device.

8. The sample size for the training set:

Not applicable / Not available. This device is a hardware digital X-ray capture system, not an AI or algorithm-driven diagnostic tool in the sense of requiring a "training set" of data to learn from.

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

Not applicable / Not available. Similar to point 8, this question is not relevant for this type of device and submission.

Summary

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OCT 1 3 1999

K99 2547

510(k) Summary

CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 TELEPHONE (516) 328-5000 GENERAL FAX TELEPHONE (516) 328-5009

Prepared:

July 19, 1999

Submitter:

Canon USA, Inc. (U.S. designated agent for Canon Inc.) Company Name: Company Address: One Canon Plaza Lake Success, NY 11042 Ken Shadoff, Senior Product Safety Engineer Contact Person: (216) 328-5602 Phone Number: (516) 328-5169

Proposed Device:

Fax Number:

Reason For 510(k):	New Model
Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	CXDI-22
Classification Name:	MQB, Solid State X-ray Imager
FDA 510(k) #:	To be assigned

Predicate Device:

Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	CXDI-11
Classification Name:	90MQB, Solid State X-ray Image
FDA 510(k) #:	K981556

Description Of Device:

Canon X-ray digital camera CXDI-22 is different from CXDI-11 in the following respect:

· Model CXDI-11 operates in conjunction with an upright stand, while model CXDI-
- 22 is a retrofit kit for installation into an existing radiologic table.

Intended Use:

Canon X-ray digital camera CXDI-22 provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Technical Characteristics:

Please refer to the attached COMPARISON CHART.

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Table of comparison

Item		CXDI-11	CXDI-22
Intended Use		Provide diagnostic images for general radiography with upright system	Provide diagnostic images for general radiography with table system
Desgin		Digital acquisistion, electronic processing	Same
Energy Uses		Receives x-radiation generated by external x-ray generator	Same
Materials	X-ray Absorber	Fluorescent screen( $Gd_2O_2S:TB^{3+}$ )Visible emission peak: 545nm	Same
	Sensing Means	Amorphous Silicon W/TFT Array Detection peak:540-620nm	Same
Anatomical Sites		General radiography	Same
Target Population		General population	Same
Physical Safety		Minimize exposure to x-radiation	Same
Compliance with Standard		Complies with IEC 601-1-2	Same
Biocompatibility		N/A	N/A
Performance		After digital processing(optimize the gray-scale)	Same
Labeling		Approved 510(K)	See attachment labeling
MTF		MTF@2lp/mm 42%	Same
Dynamic Range		Dyanamic range:approximately 4 digit(linear A/D : 14bit)(output data : 12bit)	Same
Sensor Unit		552 x 598 x 231mm	604 x 645 x 73.5or69mm
Power Supply		580 x 489 x 275mm	390 x 160 x 110mm
Control PC		483.5 x 594 x 300mm	453 x 594 x 300mm
Operation Unit		298 x 209.5 x 130mm	Same
Card Reader		50 x 180 x 39mm	Same
Stand		900 x 475 x 2100mm	N/A
Table		N/A	N/A

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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 emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, sans-serif font. The emblem features a stylized representation of a human figure within a circular border.

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

Mr. Ken Shadoff Senior Product Safety Engineer Canon USA. Inc. One Canon Plaza LAKE SUCCESS NY 11042-1198

AUG 23 2013

Re: K992547

Trade/Device Name: Model CXDI-22 X-ray Digital Camera Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 29, 1999 Received: July 30, 1999

Dear Mr. Shadoff:

This letter corrects our substantially equivalent letter of October 13, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 510(x) promants is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed interstate for use stated in the encrosule) to regary manated to the Medical Device Amendments, or to commerce prior to May 20, 1970, the character with the provisions of the Federal Food, Drug, devices that nave been recials in accorded in accorded approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosmelle Act (Act) that do not require apple on the general controls provisions of the Act. The You may, defector, market the device, sayler to increasents for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the fict mention and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) into enose (ope your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Code of Poucharts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that FDA s issualled of a succession with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA lias made a decemmation that your seered by other Federal agencies. You must a or any Peteral statules and regulations adminities, but not limited to: registing (21)
comply with all the Act's requirements, including, but not limited to secting of comply with all the Act 3 requirements, incrueing, Strates call device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related aurelse ovense (OS) regulation (21 CFR Part 820). This letter requirements as set forur in the quality of the as described in your Section 510(k) prematet will allow you to begin marketing your active af your device to a legally marketed nothication. The FDA midnig of backan 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 CFF) Parts 801 and If you desire specific advice for your device of the Evaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device Eyaluation and arcrease 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 1450. Also, please note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 CFR Pat 005), promo go go 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 Statement

K992547 510(K)Number(if known):

CKDI-22 Device Name:

Indications for Use:

CANON X-RAY DIGITAL CAMERA CXDI-22 provides digital image capture for conventional film/screen radiographic examinations.

The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT NEEDE

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Page

David A. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

ರ್ಥಿಗಳು

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.