Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20

K221955 · Realcloud Imaging Inc. Dba Realcloud Imaging · MUH · Aug 31, 2022 · Dental

Device Facts

• Record ID: K221955
• Device Name: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
• Applicant: Realcloud Imaging Inc. Dba Realcloud Imaging
• Product Code: MUH · Dental
• Decision Date: Aug 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Brasseler GEM is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. Brasseler GEM can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images for patients receiving intraoral x-ray examinations for diagnostic purposes. An image analysis software is not part of this submission. When Brasseler GEM is to be used in a dental practice, an optional software will be necessary. Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy.

Device Story

USB-driven digital intraoral x-ray sensor; utilizes CMOS imager with Cesium Iodide scintillator to capture x-ray doses; converts radiation to digital images. Used in dental clinics by trained professionals; positioned in patient mouth manually or with holders. Device connects to PC via USB; requires third-party image analysis software for optimization, archiving, and printing. Firmware controls sensor activation and dose optimization. Provides 2D images for diagnosis of dental anatomy and pathologies; aids clinical decision-making; reduces radiation exposure compared to analog film.

Clinical Evidence

Clinical performance testing provided via clinical images to demonstrate system functionality compared to predicate. Bench testing performed per ANSI/AAMI ES 60601-1, IEC 62304, IEC 60529, IEC 60601-1-2, and EN 60601-1-2.

Technological Characteristics

CMOS x-ray imager with Cesium Iodide scintillator; USB 2.0 Type A interface; IPx8 equivalent housing (SABIC resin); biocompatible per ISO 10993. Dimensions vary by model (GEM10, GEM15, GEM20). Power: 0.8W max, DC 5V. Not sterile. Software: Moderate Level of Concern firmware.

Indications for Use

Indicated for acquisition of dental radiographic images in patients of any age. Must be operated by trained, competent healthcare professionals. Used with dental positioning devices or hand-aligned with patient assistance. Contraindicated for extraoral or non-dental x-ray applications.

Regulatory Classification

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.

Predicate Devices

• Clio Prime (K202664)

Submission Summary (Full Text)

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August 31, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that 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.

RealCloud Imaging Inc. dba RealCloud Imaging % Mr. W. Edward Johansen Official Correspondent W. Edward Johansen 1239 Stanford Street, Apartment Number 205 SANTA MONICA CA 90404

#### Re: K221955

Trade/Device Name: Brasseler GEM Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 1, 2022 Received: July 5, 2022

#### Dear Mr. Johansen:

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

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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,

Laurel Burk, 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

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#### Indications for Use

#### 510(k) Number (if known) K221955

Device Name

#### Brasseler GEM

Indications for Use (Describe)

Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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#### 510(k) Summary - K221955

Submitted: July 27, 2022

### A. Corporation Information

Name: RealCloud Imaging Inc.

Address: 2625 North Loop Drive, Suite 2130, Ames, Iowa 50010

Telephone:[phone]

E-mail address: [e-mail]

Official Correspondent: W. Edward Johansen

Telephone: [phone]

E-mail address: [e-mail]

Address: 1239 Stanford Street, #205, Santa Monica, California 90404

#### B. Identification of New Device

Owner/Operator: RealCloud Imaging Inc. doing business as RealCloud Imaging

Owner/Operator Number: 10052982

Establishment Registration Number: 3013464458

Trade Name: Brasseler GEM

Premarket Notification Number: K221955

Common Name: Dental digital x-ray sensor

Classification Name: Extra-oral source x-ray system

Product Code: MUH

Class: Il

Panel/Medical Specialty: Radiology/Dental

Regulation Number: 21 C.F.R. §872.1800

Manufacturer: RealCloud Imaging

Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE

Systems Inc.

Sterilization Facility: Not Applicable

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#### C. Identification of Predicate Device

Owner/Operator: SOTA Precision Optics, Inc. doing business as SOTA Imaging

Owner/Operator Number: 905754

Establishment Registration Number: 3000190675

510(k) Premarket Notification Number: K202664

Trade Name: Clio Prime

Common Name: Dental intraoral x-ray sensor

Classification Name: Extra-oral source x-ray system

Product Code: MUH

Classification: Class II

Panel/Medical Specialty: Radiology/Dental

Regulation Number: 21 C.F.R. §872.1800

Manufacturer: Sota Precision Optics, Inc. dba SOTA Imaging

Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE

Systems Inc.

Sterilization Facility: Not Applicable

#### D. Device Description

Brasseler GEM is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intraoral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgement, and experience.

Brasseler GEM10 is for pediatric use and adult periapical use, GEM15 is for pediatric and adult bitewing and periapical use, and GEM20 is for adult use including bitewings. The Brasseler GEM design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Brasseler GEM is positioned in the patient's mouth in the same manner as intraoral film is positioned.

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Brasseler GEM has a CMOS x-ray imager that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Brasseler GEM through the standard USB port. Image analysis software is not part of the submission. For Brasseler GEM to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. Brasseler GEM capture x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis thereby subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient. Functions of the Brasseler GEM detector are controlled by software (firmware). The software of Brasseler GEM is of Moderate Level of Concern and is not based on the software of the predicate, Clio Prime.

Brasseler GEM shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Brasseler GEM can be used either in combination with positioners manufactured to facilitate the positioning and alignment with an x-ray beam, or it may also be positioned by hand with the assistance of the patient. Brasseler GEM can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized. Using Brasseler GEM is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis. Brasseler GEM can perform and achieve the same type of two-dimensional images as conventional (traditional) film sizes 0, 1 and 2. Brasseler GEM cannot be used to, or as a substitution for extraoral or other types of dental x-ray. When using Brasseler GEM and software as a diagnostic aide, clinical experience and a combination of the diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.

#### E. Indications for Use

Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy.

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Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.

## F. Intended Use

Brasseler GEM is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. Brasseler GEM can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images for patients receiving intraoral x-ray examinations for diagnostic purposes. An image analysis software is not part of this submission. When Brasseler GEM is to be used in a dental practice, an optional software will be necessary. Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy.

## G. Performance Testing-Animal

RealCloud Imaging did not perform animal performance testing.

## H. Performance Testing-Bench

On behalf of RealCloud Imaging Intertek performed extensive bench testing on Brasseler GEM in accordance with the following reference standards: ANSI AMI ES 60601-1; IEC 62304; IEC 60529; IEC 60601-1-2; and EN 60601-1-2.

#### Comparison Table

The following comparison table compares Brasseler GEM to the predicate device, Clio Prime, with respect to intended use, indications of use, environment of use, limitations of use, technical performance, and technological characteristics, and provides more detailed information regarding the basis for the determination of substantial equivalence.

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# Comparison Table

| Descriptive<br>Information | Brasseler GEM | Clio Prime |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K221955 | K202664 |
| Manufacturer | RealCloud Imaging<br>Inc. doing business as<br>RealCloud Imaging | Sota Precision Optics,<br>Inc. doing business as<br>SOTA Imaging |
| Trade Name | Brasseler GEM10<br>Brasseler GEM15<br>Brasseler GEM20 | Clio Prime<br>Clio Pedo |
| Classification Name | Digital x-ray sensor | Digital x-ray sensor |
| Classification | Class II | Class II |
| Classification Panel/<br>Medical Specialty | Radiology/Dental | Radiology/Dental |
| Regulation Number | 21 C.F.R. §872.1800 | 21 C.F.R. §872.1800 |
| Product Code | MUH | MUH |
| Number of Sensors | 3 | 2 |
| Sensor Exterior Sizes | 36.36 mm x 24.53.mm<br>38.83 mm x 29.63 mm<br>41.80 mm x 30.48 mm | 36.31 mm x 30.42 mm<br>41.76 mm x 30.42 mm |
| Sensor Imaging Sizes | 30.26 mm x 20.32 mm<br>33.15 mm x 26.25 mm<br>36.08 mm x 26.25 mm<br>All with four clipped<br>corners | 30.26 mm x 20.32 mm<br>36.08 mm x 26.25 mm<br>All with four clipped<br>corners |
| Overall Imaging Areas | 615 mm2<br>870 mm2<br>947.1mm2 | 615.0 mm2<br>947.1 mm2 |
| Pixel Size | 19.5 µm | 19.5 µm |
| Imager Resolution | 1539 x 1026 pixels<br>(1.70 M pixels)<br>1692 x 1324 pixels<br>(2.2 M Pixels)<br>1842 x 1324 pixels<br>(2.40 M pixels) | 1539 x 1042 pixels<br>(1.70 M Pixels)<br>1842 x 1342 pixels<br>(2.40 M Pixels) |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm |
| Dynamic Range | 16,384:1 | 16,384:1 |
| Technology | CMOS | CMOS |
| Scintillator Technology | Cesium lodide | Cesium lodide |
| Operating System | Microsoft Windows 7<br>and 10 | Microsoft Windows 7<br>and 10 |
| Extraoral source | x-ray system | x-ray system |
| Interface to PC | USB 2.0, Type A | USB 2.0, Type A |
| Cable Length | 1.9 m and 2.9 m | 1.9 m and 2.9 m |
| Power Consumption | 0.8 Watts Max | 0.8 Watts Max |
| Electrical Rating | DC 5V, 350 mA max…