(87 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on converting analog film to digital images, which is a standard digitization process.
No
The device converts analog x-ray films to digital images for review and analysis; it does not directly treat or diagnose a medical condition.
Yes
The device is explicitly indicated for the "digitization of mammography images for review and analysis," which are steps in the diagnostic process. While it states it's "not as the sole basis for screening or diagnosis," its purpose is to provide images for those activities.
No
The device description explicitly states it is an "electronic device used to convert analog x-ray film to digital images," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device's intended use is to convert analog medical x-ray films (which are images of the body, not specimens derived from it) into digital images.
- The device description clearly states it's an "electronic device used to convert analog x-ray film to digital images."
The device is a medical device used in the process of reviewing and analyzing medical images, but it does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The intended use of the MAMMOGRAPHY PRO and Diagnostic PRO-M is to produce digital copies of medical x-ray films.
"The MAMMOGRAPHY PRO and Diagnostic PRO-M are indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis."
The MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers are intended for coveting analog Medical x-ray films to digital images.
The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.
Product codes
892.2040
Device Description
The x-ray film digitizer, an electronic device used to convert analog x-ray film to digital images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray film
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
510 (k) Summary As required by 807.92 For the MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers Prepared on January 17, 2000
| Submitted by: | VIDAR Systems Corporation
460 Spring Park Place
Herndon, VA 20170
Telephone: (703) 471-7070
Fax: (703) 471-1165 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Drinkard
Medical Business Program Manager |
| Device Trade Name: | MAMMOGRAPHY PRO and Diagnostic PRO-M x-ray film digitizers. |
| Common Name: | X-ray film digitizer |
| Classification: | Medical image digitizers were reviewed by the Radiology panel and are
classified in Class 11 per CFR 892.2040 (proposed). |
| Predicate Device: | MedScan 12 (K933632) |
| Manufactured by: | VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170 |
| Description of Device: | The x-ray film digitizer, an electronic device used to convert analog x-ray film
to digital images. |
| Intended use for the device: | |
The intended use of the MAMMOGRAPHY PRO and Diagnostic PRO-M is to produce digital copies of medical x-ray films.
"The MAMMOGRAPHY PRO and Diagnostic PRO-M are indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis."
Substantial Equivalence to Predicate Device:
The MAMMOGRAPHY PRO and Diagnostic PRO-M are substantially equivalent to the MedScan 12 (K933632) film digitizer manufactured by VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170. Technical differences between the devices and the predicate raise no new issues of safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized image of an eagle's head with three lines representing the feathers. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2000
Mary "Pennie" Drinkard Medical Business Line Program Manager Vidar Systems Corporation 460 Spring Park Place Herndon, VA 20170
Re: K993598 Mammography Pro and Diagnostic PRO-M Dated: September 15, 1999 Received: October 25, 1999 Regulatory class: II 21 CFR 892.2030/90 LMA
Dear Ms. Drinkard:
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 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 either class III (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 the Electronic Product 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 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/dsmaldsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K993598
Device Name: MAMMOGRAPHY PRO and Diagnostic PRO-M
Indications for Use:
The MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers are intended for coveting analog Medical x-ray films to digital images.
The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devices Evaluation (ODE)
Thrid G. Sermo
(Division Si
(Division Sign-Off) (Forision Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Deproduct 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-the Counter-Use_