(76 days)
Not Found
No
The summary describes a digital radiography system with image display, enhancement, and storage capabilities, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
Explanation: The device is an X-ray system used for digital dental radiography and image processing for diagnostic purposes, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is intended for "radiographic diagnostic intraoral and extraoral exposures," indicating its use in diagnosing conditions.
No
The device description explicitly states it consists of reusable phosphor storage screens and an image reader/digitizer, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The ScanARay Advanced Computerized X-Ray System is an imaging system that uses X-rays to create digital radiographs of teeth and surrounding structures. It does not analyze biological samples.
- Intended Use: The intended use is for "digital dental radiography for radiographic diagnostic intraoral and extraoral exposures." This clearly describes an imaging process, not an in vitro test.
Therefore, the ScanARay system falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for 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.
Product codes
IXK, LMA
Device Description
The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and extraoral radiography using a phosphor storage screen. It enables the dentist to scan or import images for display, review or storage in a database. It consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a user-provided personal computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Dental (intraoral and extraoral)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
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.
0
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: | (914) 592-6100 |
|---|---|
| Facsimile: | (914) 592-6148 |
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:
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
1
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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2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
510(k) Number (if known):
Device Name: __________________
Indications For Use:
4 :
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
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)