SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM

K974619 · Afp Imaging Corp. · LMA · Feb 25, 1998 · Radiology

Device Facts

• Record ID: K974619
• Device Name: SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
• Applicant: Afp Imaging Corp.
• Product Code: LMA · Radiology
• Decision Date: Feb 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.

Device Story

System captures dental X-ray images using reusable phosphor storage screens; reader/digitizer converts latent images from screens into digital format; software on user-provided PC displays, enhances, and stores images in a database. Used in dental clinics by dental professionals for diagnostic imaging. Output allows dentists to review and analyze radiographs to support clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of reusable phosphor storage screens, image reader/digitizer, and software. Operates as a filmless digital radiography system. Connectivity via user-provided PC. No specific materials or software architecture details provided.

Indications for Use

Indicated for digital dental radiography, including intraoral and extraoral radiographic diagnostic exposures.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Digora (K934949)
• DerOptix System (K955643)

Submission Summary (Full Text)

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K974619

FEB 2 5 1998

# 510(k) Summary for ScanARay Advanced Computerized X-Ray System

- December 10, 1997 DATE SUMMARY PREPARED: 1.
- SUBMITTER'S NAME AND ADDRESS 2.

AFP Imaging 250 Clearbrook Road Elmsford, NY 10523

- CONTACT PERSON 3.
Mr. David Vozick

| Telephone: | [phone] |
|------------|----------------|
| Facsimile: | [phone] |

### 4. DEVICE NAME

ﺑﻪ ﻭ ScanARay/CD-Dent Advanced Computerized X-Ray Trade/Proprietary Name: System Electrostatic X-Ray imaging system (Dental) Common Name: Classification Name: Electrostatic X-Ray imaging system

#### 5. PREDICATE DEVICES

The legally marketed devices to which equivalence is being claimed are:

- Digora marketed by Sorodex-finndent (K934949) .
- DerOptix System marketed by Gendex (K955643) .

# DEVICE DESCRIPTION 6.

The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and extraoral radiography using a phosphor storage

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screen. It enables the dentist to scan or import images for display, review or It consists of reusable phosphor storage screens for storage in a database. recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a user-provided personal computer.

## 7. INTENDED USE

The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1998

Mary M. McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K974619 AFP Imaging ScanARay (CD-Dent) Advanced Computerized X-Ray System Dated: December 10, 1997 Received: December 11, 1997 Regulatory class: II 21 CFR 892.1630/Procode: 90 IXK/90 LMA

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). You may, therefore, whice 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 either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html/"-------

Sincerely yours.

hồ tiêu Yến

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: __________________

Indications For Use:

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The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K974619 |

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR Over-The-Counter Use ______

(Optional Format 1-2-96)