PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

• K Number: K112974
• Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer: CURVE DENTAL, INC.
• Date Cleared: 2011-10-20 ( 15 days)
• Product Code: LLZ
• Regulation Number: 892.2050

Intended Use

CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.

Device Description

Curve Image is a web-based dental practice image management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer. Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called HERO.

Predicate Devices

K982422, K083018

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard PACS system with image management and editing capabilities, and there is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is described as image management software (PACS) for dental offices, designed to store, manage, and display digital images for diagnostic use. It does not provide any treatment or therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The system is designed to provide images for diagnostic use." Additionally, the "Device Description" mentions that images are "available for both diagnostic and non-diagnostic use."

SaMD (Software as a Medical Device)

Yes

The device is described as "internet-based, image management software (PACS)" and a "web-based dental practice image management system" that is accessed via an internet connection and does not require software installation on the user's computer. While it interacts with images from hardware devices, the device itself is solely the software system for managing and processing these images.

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 Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Curve Image's Function: Curve Image is an image management software (PACS) for dental offices. Its primary function is to acquire, store, manage, and display digital images of hard and soft tissue charts. It facilitates the viewing and manipulation of these images for diagnostic use by dental professionals.
• Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the patient. It works directly with digital images acquired from imaging devices or uploaded by the user.

While the system is used for "diagnostic use" in the context of dental imaging, this refers to the interpretation of the images by a trained professional, not an in vitro diagnostic test performed by the device itself on a biological sample.

The predicate devices listed (PACS systems) further support that this is categorized as a medical image management system, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.

Product codes

LLZ

Device Description

Curve Image is a web-based dental practice image management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer.

Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called HERO.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hard and soft tissue charts

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental offices, 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)

Curve Dental, Inc. has conducted extensive non-clinical and validation testing of the Curve Image system, as a PACS system that is capable of providing reliable post-processing and display of images for dental applications. All of the different components of the Curve Image software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate devices.

The tests performed included:

• Product Risk Assessment
• Software modules verification tests
• Software validation test

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

Not Found

Predicate Device(s)

K982422, K083018

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

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510(k) Summary (in accordance with 21 CFR 807.92)

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

I. Applicant Information

| Applicant: | Curve Dental, Inc.
424 W. 800 N.
Suite 202
Orem, UT 84057 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | George Stantchev
Director Imaging
Tel: [phone]
Fax: [phone]
e-mail: [e-mail] |

June 20, 2011 Date Prepared:

11. Device Name and Classification

Proprietary Name:	Curve Image 2.0
Classification Name:	Picture Archiving and Communications System
Common/Usual Name:	PACS
Classification:	Class II
Regulation Number:	892.2050
Product Codes:	LLZ
Classification Panel:	Radiology Devices

III. Predicate Devices

The Curve Image device is substantially equivalent to the following FDA cleared predicate devices with regard to indications for use, performance and technological characteristics:

510(k) Number:	K982422
Trade Name:	ChairSide Software Application
Manufacturer:	EagleSoft
Classification Name:	Picture Archiving and Communications System
Common/Usual Name:	PACS
Classification:	Class II
Regulation Number:	892.2050
Product Codes:	LLZ

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510(k) Number: Trade Name: Manufacturer: Classification Name: Common/Usual Name: PACS Classification: Regulation Number: Product Codes:

K083018

Centricity PACS Web Diagnostic (Web DX) PACS GE Healthcare Dynamic Imaging Solutions Picture Archiving and Communications System Class II 892.2050 LLZ

IV. Device Description

Curve Image is a web-based dental practice image management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer.

Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called HERO.

V. Intended Use

Curve Image is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.

VI. Summary of the Technical Characteristics

Curve Image software provides the following high-level features:

• . Browsing Images by Date and/or Source
• . Viewing an Image

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• Uploading an Image File .
• Acquiring an Image from a Web Camera .
• Acquiring an Image from a TWAIN Device ●
• Acquiring image from Dental Imaging Device ●
• Copying an Image to the Local Computer .
• Saving a Modified Image .
• Annotating an Image t
• Zooming In on an Image .
• Cropping an Image
• Inverting Colors of an Image .
• Rotating an Image (increments of 90 degrees) �
• Flipping an Image Horizontally or Vertically ●
• Increasing/Decreasing Image Brightness
• Increasing/Decreasing Image Contrast

The main technical characteristics of the software are:

• . Web-based Application and Interface
• Secure Data Transmission (HTTPS) .
• . Database Management and Storage
• Secure Server Infrastructure .

Expanded software features:

• Administration .
• Patient management .
• Scheduling ●
• Billing �
• Insurance Management .
• . Claims Management
• Dental Charting
• Perio Charting .
• Patient Notes and History .
• . Prescriptions
• Patient Education ●

The following table compares Curve Image to the predicate devices with respect to intended use, environment of use, limitations of use, technical performance and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.

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| Device Name | Curve Image | ChairSide Software Application
(K982422) | Centricity PACS Web Diagnostic (Web DX) PACS (K083018) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ | LLZ | LLZ |
| Regulation # | 892.2050 | 892.2050 | 892.2050 |
| Class | II | II | II |
| Intended Use | CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. | EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audit recording and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public.

Images can be acquired from standard dental imaging devices including Digital Radiographic Devices, Digital Video Capture Devices and General Image Devices such as scanners. Images can be edited (e.g., resized, contrast, cropped, etc.), as well as | Centricity PACS Web Diagnostic (Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA. |

CONFIDENTIAL

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510(k) – Curve Image

K112974
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Device Name	Curve Image	ChairSide Software Application (K982422)	Centricity PACS Web Diagnostic (Web DX) PACS (K083018)
	The system is designed to provide images for diagnostic use.	imported or exported.	Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Environment of Use	Dental offices.	Dental offices.	Hospitals, clinics and physicians offices.
Performance Characteristics & Principles of Operation	Basic Technology:
Web-based, software application.	Basic Technology:
PC-based, software application.	Basic Technology:
Web-based, software application.
	Features:
Browsing Images by Date and/or Source Viewing an Image Uploading an Image File Acquiring an Image from a Web Camera Acquiring an Image from a TWAIN Device	Features:
Browsing Images by Date and/or Source Viewing an Image Uploading an Image File Acquiring an Image from a Web Camera Acquiring an Image from a TWAIN Device Acquiring image from standard dental imaging devices Copying an Image to the Local Computer Saving a Modified Image	Features:
Browsing Images by Date and/or Source Viewing an Image Uploading an Image File Acquiring an Image from a Web Camera Acquiring an Image from a TWAIN Device Copying an Image to the Local Computer Saving a Modified Image
Device Name	Curve Image	ChairSide Software Application (K982422)	Centricity PACS Web Diagnostic (Web DX) PACS (K083018)
	Annotating an Image Zooming In on an Image Cropping an Image Inverting Colors of an Image Rotating an Image (increments of 90 degrees) Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Lossless image compression Zoom dept: absolute 1x, Fit and relative Technical Characteristics: Web-based Application and Interface Secure Data Transmission	Annotating an Image Zooming In on an Image Cropping an Image Inverting Colors of an Image Rotating an Image (increments of 90 degrees) Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Image measurements DICOM Compliance Video Capture 3D Image view JPG image lossy compression Zoom depth: absolute 1x, Fit and relative Technical Characteristics: PC-based Application and Interface	Annotating an Image Zooming In on an Image Inverting Colors of an Image Rotating an Image (increments of 90 degrees) Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Image measurements DICOM Compliance 3D Image view JPEG and wavelet lossy image compression Zoom depth: absolute 1x, 2x, 4x, 8x and relative Technical Characteristics: Web-based Application and Interface Secure Data Transmission

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510(k) — Curve Image

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510(k) - Curve Imag

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| Device Name | | Curve Image | | ChairSide Software Application
(K982422) | Centricity PACS Web
Diagnostic (Web DX) PACS
(K083018) | |
|-------------------------|---|----------------------------------------------------------------------------------------------------------------------------|---|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--|
| | | (HTTPS) | | | (HTTPS) | |
| | | • Database Management and
Storage | | • Database Management and
Storage | • Database Management and
Storage | |
| | | • Secure Server Infrastructure | | | • Secure Server Infrastructure | |
| Administration | | • User login | | • User login | • User login | |
| | | • Account management | • | • Account management | • Account management | |
| | | • Security administration
privileges for Administrator,
Basic User, Clinical User
and Practice Management
User | | • Security administration
privileges for Administrator,
Basic User, Clinical User
and Practice Management
User | • Security administration
privileges for Administrator,
Basic User and Clinical | |
| Patient
management | | • Patient profile and data
management | | • Patient profile and data
management | • Patient profile and data
management | |
| Scheduling | | • Appointment managements
functions with calendar | | • Appointment managements
functions with calendar | | |
| Billing | • | Setting up billing and
insurance information | | Setting up billing and
insurance information | | |
| Insurance
Management | | Retrieve Insurance
payments | | Retrieve Insurance
payments | | |
| Claims | | Create and manage | | Create and manage | | |
| | | | | | | |

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510(k) – Curve Image

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| Device Name | Curve Image | ChairSide Software Application
(K982422) | Centricity PACS Web
Diagnostic (Web DX) PACS
(K083018) |
|------------------------------|---------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------|
| Management | Insurance claims | Insurance claims | |
| Dental Charting | • Dental Chart layout and
treatment plans management | • Dental Chart layout and
treatment plans management | |
| Perio Charting | • Perio Chart, perio exam and
perio graph management | • Perio Chart, perio exam and
perio graph management | |
| Patient notes and
History | • Patient text notes, note
history | • Patient text notes, note
history | • Keynotes on patient data |
| Prescriptions | • Prescription notepad writer | • Prescription notepad writer | |
| Patient Education | • Patient education movies
and interface | • Patient education movies
and interface | |

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510(k) — Curve Image

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Image /page/8/Picture/0 description: The image shows the text "K112974" at the top, followed by "Page 9 of 9". Below this text is the logo for "curvedental". The logo features a circular arrangement of dots on the left, followed by the word "curve" in bold and "dental" in a regular font.

VII. Summary of Non-Clinical Testing

Curve Dental, Inc. has conducted extensive non-clinical and validation testing of the Curve Image system, as a PACS system that is capable of providing reliable post-processing and display of images for dental applications. All of the different components of the Curve Image software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate devices.

The tests performed included:

• . Product Risk Assessment
• . Software modules verification tests
• Software validation test .

VIII. Conclusions

Based on the comparison of intended use and technological characteristics, the Curve Image system is substantially equivalent to the ChairSide Software Application manufactured by EagleSoft (K982422) and the Centricity PACS Web Diagnostic (Web DX) PACS manufactured by GE Healthcare Dynamic Imaging Solutions.

Curve Image combines the web-based technology of the Centricity PACS, with the features and functionality of the ChairSide Software. Therefore the Curve Image device is substantially equivalent to the predicate devices.

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Curve Dental, Inc. % Mr. Casey Conry Staff Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747

OCT 2 0 2011

Re: K112974

Trade/Device Name: CURVE IMAGE Trade/Don Number: 21 CFR 892.2050 Regulation Name: 21 CF FC 69212001 - 12 communications system Regulatory Class: II Product Code: LLZ Dated: October 3, 2011 Received: October 5, 2011

Dear Mr. Conry:

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, 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary. S Pastel

Mary S. Pastel, Sc.D. 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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4. Indication for Use Statement

510(k) Number (if known):

Device Name: CURVE IMAGE

Indications for Use:

CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.

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 Diagnostic Devices (OIVD)

May S. Pastel

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112974

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