Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard digital image processing techniques (filtering, gain/offset correction, flat fielding) and does not mention any AI or ML algorithms.

Therapeutic

No
The device is an imaging system designed for capturing and processing X-ray images for diagnostic purposes, not for treating diseases or conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" states it is for "capturing, digitization and processing of intra oral x-ray images", and the "Device Description" explains it "produces the X-ray diagnostic image in digital format." Additionally, the "Summary of Performance Studies" indicates it "represents an effect for diagnosis of patient." These directly indicate its role in providing diagnostic images for medical diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical Computed Radiography Reader that utilizes hardware components like a laser, light collection system, and signal processing unit to convert latent images from X-ray plates into digital format. While it involves software for image processing and viewing, it is fundamentally a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the FireCR Dental imaging system is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The FireCR Dental system is used to capture and process X-ray images of the inside of the mouth (intra oral). This is imaging of the body itself, not analysis of a biological sample taken from the body.
The intended use is for capturing, digitizing, and processing intra oral x-ray images. This is a diagnostic imaging device, not a device for testing biological samples.
The device description details the process of converting X-ray exposure into a digital image. This process involves physical and digital manipulation of the image data, not chemical or biological analysis of a specimen.

Therefore, the FireCR Dental imaging system falls under the category of a medical imaging device, specifically a computed radiography reader for dental applications, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Fire R Dental Imaging System is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.

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

MUH

Device Description

The FireCR Dental is Computed Radiography Reader which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (Imaging Plate) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collected and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system.

After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.

Main Feature: The full-featured Fire CR Dental Reader from 3D Imaging & Simulations Corp. rapidly and affordably delivers high-quality digital images for busy dental practices.

Compact & Affordable: The FireCR Dental Reader is compact and affordable, helping to increase patient throughput and improve the overall productivity of your practice. With its small footprint, the reader fits seamlessly into even the most space-challenged dental offices and exam rooms.

Elegant Design & Streamlined Operation: The FireCR Dental Reader's elegant design belies a powerful yet easy-to-use system that gets the job done day in and day out.

The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost, reusable bitewing and intraoral imaging plates that are easier and faster to position than intraoral digital sensors.

Product features:

Photomultiplier Tube .(PMT)
IP size : 0, 1, 2, 3 and 4c
Wide dynamic range with 16-bit digitization
DICOM3.0 standard compliance
User Selectable Scanning Resolution : 35um and 64um

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

intra-oral

Indicated Patient Age Range

Not Found

Intended User / Care Setting

busy dental practices

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)

Non-clinical & Clinical considerations according to FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

In clinical considerations,

The rating was considered equivalent by dentists.
As a result of Clinical Study, FireCR Dental is considered that Image quality is equivalent to the Predicate Device. And FireCR Dental represents an effect for diagnosis of patient.

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.

K041050

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.

Not Found

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

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.

Summary

0

Page 1 of 5

510(k) Summary for K131442

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

Date Prepared: September 3, 2013

Company and Correspondent making the submission:

Name - 3D Imaging & Simulations Corp. Address - 815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea Telephone - +82-42-931-2100 Fax - +82-42-931-2299 Contact - Jiin Jung / COO E-mail - jij@3DISCimaging.com

SEP 06 2013

2. Device :

·

Trade/proprietary name	: FireCR Dental
Common Name	: Computed Radiography Scanner System
Classification Name	: Extraoral source x-ray system

1. Predicate Devices :

Manufacturer	: Soredex
Device	: DIGORA Optime
510(k) Number	: K041050 (Decision Date - Apr. 19. 2004)

4. Classification Name & Citations :

Extraoral source x-ray system., 21 CFR 872.1800, Pro Code MUH.

5. Description :

5.1 General
The FireCR Dental is Computed Radiography Reader which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (Imaging Plate) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collected and converted into a form of digital image. The signal processing is made to

815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea

1

the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system.

After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.

5.2 Main Feature

Experience the Benefits of Digital Imaging

The full-featured Fire CR Dental Reader from 3D Imaging & Simulations Corp. rapidly and affordably delivers high-quality digital images for busy dental practices.

Compact & Affordable

The FireCR Dental Reader is compact and affordable, helping to increase patient throughput and improve the overall productivity of your practice. With its small footprint, the reader fits seamlessly into even the most space-challenged dental offices and exam rooms.

Elegant Design & Streamlined Operation

The FireCR Dental Reader's elegant design belies a powerful yet easy-to-use system that gets the job done day in and day out.

The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost, reusable bitewing and intraoral imaging plates that are easier and faster to position than intraoral digital sensors.

5.3 Product features

Photomultiplier Tube .(PMT)
IP size : 0, 1, 2, 3 and 4c
Wide dynamic range with 16-bit digitization
DICOM3.0 standard compliance
User Selectable Scanning Resolution : 35um and 64um

6. Indication for use :

The FireCR Dental imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media

7. Comparison with predicate device :

3D Imaging & Simulations Corp. believes that the Dental Computed Radiography Reader

10.53 - 10.0 - 10.0 - 10.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 -

815, Tamnip-Dong , Yuseong-Gu, Daejeon, Korea

2

(FireCR Dental) is substantially equivalent to DIGORA Optime of Soredex.

| | | FireCR Dental
3D Imaging & Simulations Corp. | DIGORA Optime
Soredex |
|---------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) number | - | K041050 |
| | Intended Use | This device is a Dental
Computed Radiography System
and intended for use in
producing digital X-Ray images
for dental radiography (intra oral)
purposes. | The Digora Optime imaging
system is indicated for capturing,
digitization and processing of
intra oral x-ray images stored in
imaging plate recording media. |
| Physical
Char. | Overall
Dimensions | Reader
185 x 100 x 293mm | Reader
190 x 200 x 383mm |
| | Imaging Area | Size 0 : 22 x 31mm
Size 1 : 24 x 40mm
Size 2 : 31 x 41mm
Size 3 : 27 x 54mm
Size 4c : 48 x 54mm | Size 0 : 22 x 31mm
Size 1 : 24 x 40mm
Size 2 : 31 x 41mm
Size 3 : 27 x 54mm
Size 4c : 48 x 54mm |
| | Effective Pixel
Pitch | 35um, 64um | 35um, 64um |
| | Spatial
Resolution | 14.3 lp/mm @ 35um
7.8 lp/mm @ 64 um | 14.3 lp/mm @ 35um
7.8 lp/mm @ 64 um |
| | Image Matrix | Size 0
343 x 484 @ 64um
628 x 885 @ 35um

Size 1
375 x 625 @ 64um
685 x 1143 @ 35um

Size 2
484 x 640 @ 64um
886 x 1171 @ 35um

Size 3
421 x 843 @ 64um
771 x 1542 @ 35um

Size 4c
750 x 843 @ 64um
1370 x 843 @ 35um | Size 0
343 x 484 @ 64um
628 x 885 @ 35um

Size 1
375 x 625 @ 64um
685 x 1143 @ 35um

Size 2
484 x 640 @ 64um
886 x 1171 @ 35um

Size 3
421 x 843 @ 64um
771 x 1542 @ 35um

815, Tamnip-Dong , Yuseong-Gu, Daejeon, Korea

3

3D Imaging & Simulations Corp

| | FireCR Dental
3D Imaging & Simulations Corp.
parameter is used | DIGORA Optime
Soredex
parameter is used |
|------------------------|----------------------------------------------------------------------|-----------------------------------------------|
| Processing | DICOM 3.0 Compliant | DICOM 3.0 Compliant |
| DICOM
Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant |

The FireCR Dental's imaging principle, physical characteristics, target population and intended use are the same as those of DIGORA Optime. However, the differences in the design are follows:

The technical specification (including Spatial Resolution, Operating Condition, DQE, MTF, Dynamic range), mechanical structure and physical appearance of the FireCR Dental is little different from the DIGORA Optime. Additional information can also be found in the FireCR Dental Operation Manual provided in this submission.
The testing of the FireCR Dental demonstrates that the performance is substantially equivalent to the predicate devices cited above.

In clinical considerations,

The rating was considered equivalent by dentists.
- As a result of Clinical Study, FireCR Dental is considered that Image quality is equivalent to the Predicate Device. And FireCR Dental represents an effect for diagnosis of patient.

The FireCR Dental described in this 510(k) has the same intended use and similar technical characteristics as the DIGORA Optime of Soredex. The similarities and differences between these systems are described in the table shown above.

The similarities are as follows.

Similarity of Intended use with DIGORA Optime

Similarity of Capturing image, Image Processing, and DICOM compatible features with DIGORA Optime

Similarity of X-ray exposing technique with DIGORA Optime
Similarity of Effective Pixel Pitch.

Similarity of Spatial resolution.

Similarity of X-ray absorber material with DIGORA Optime
Similarity of Image making process with DIGORA Optime

815, Tamnip-Dong , Yuseong-Gu, Daejeon, Korea

4

K131442
Page 5 of 5

3D Imaging & Simulations Corp.

Similarity of Energy Sources, Source to skin distance with DIGORA Optime Similarity of workstation and operating system with DIGORA Optime

A difference is as follows.

(1) Difference in Dynamic Range

DIGORA Optime's dynamic range is 14bit but FireCR Dental is 16bit. Therefore FireCR Dental shows more dynamic range in image than DIGORA Optime.

In summary, The FireCR Dental does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

Safety, EMC, Biocompatibility and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001).

Non-clinical & Clinical considerations according to FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

9. Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification 3D Imaging & Simulations Corp. concludes that the Computed Radiography Scanner System (FireCR Dental) is safe and effective and substantially equivalent to predicate devices as described herein.

1. 3D Imaging & Simulations Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Ticalih Service

Food and Drug Administration 10903 New Hammshire Avenue Document Control Center - WO060-G099 Silver Spring, MD 20993-0002

September 6. 2013

3DISC Americas % Daniel Kamm. P.E. Submission Correspondent Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K131442

FireCR Dental Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 29, 2013 Received: July 31, 2013

Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration. Insting 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 (reporting of medical

6

Page 2 - Daniel Kamm, P.E.

device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safets/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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 htmg//www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

l'or

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number (if known): K131442

Device Name: FireCR Dental Imaging System

Indications for Use:

The Fire R Dental Imaging System is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$(m h.7)$

(Division Sign-OM) Division of Radiological Bealth Office of In Viro Diagnostics and Radiological Health

510(k) K131442

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