(17 days)
Not Found
No
The summary explicitly states the device is "physically and electrically (including software) identical to the predicate" and there are no mentions of AI, DNN, or ML.
No
The device is indicated for generating radiographic images for diagnostic procedures, not for therapeutic purposes.
Yes
The device is described as an "X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures," indicating its use in diagnosing medical conditions.
No
The device description explicitly states it is a "Solid State X-ray Imaging system" and mentions it is "physically and electrically (including software) identical to the predicate," which is also an imaging system. This indicates the device includes hardware components for image acquisition.
Based on the provided information, the VIDAR Vision 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "generating radiographic images of human anatomy." This involves imaging the internal structures of the body, which is an in vivo (within the living body) process, not an in vitro (outside the living body) process.
- Device Description: The description confirms it's a "Digital Radiography Image Acquisition System," which aligns with in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples, which are hallmarks of IVD devices.
Therefore, the VIDAR Vision 2000 is a medical imaging device used for diagnostic purposes within the human body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The VIDAR Vision 2000 is indicated for use in generating radiographic images of human anatomy. It is a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures.
The VIDAR Vision 2000 is not indicated for diagnostic X-ray mammography."
Product codes (comma separated list FDA assigned to the subject device)
MQB, MOB
Device Description
The VIDAR VISION 2000 is currently manufactured by IMIX-ADR( Tampere, Finland) under the Premarket Notification of the predicate device (K974863). VIDAR intends to market this device under its own name. The device is physically and electrically (including software) identical to the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Tab 1 - Cover Letter Traditional 510(k)
TRADITIONAL 510(K) SUBMISSION
Submission Date: February 14, 2007 (Month/dd/yyyy)
Name & Address of BSI Authorized Person:
John Howlett, Head of BSI Medical Device Notified Body, BSI Group, Product Services, British Standards Institution, Maylands Avenue. Hemel Hempstead, Herts HP2 4SQ ામ
Phone: 011- 44-1442-278507 FAX: 011-44-1442-278575
Name & Address of BSI Technical Reviewer:
Andre Routh, PhD., Senior Product Expert, BSI Product Services - Healthcare, 12110 Sunset Hills Road, Suite 200 Reston, VA 20190
Phone/FAX: 609-654-1600
Name & Address of 510(K) Submitter:
Carrie L. Brancart VIDAR Systems Corporation 365 Herndon Parkway Herndon, VA 20170
Phone: 703-471-7070 FAX: 703-471-1165
Date received: February 05, 2007
Device Trade Name: VIDAR Vision 2000 Device Common Name: Digital Radiography Image Acquisition System
FDA Classification:
Device Class: II Panel: Radiology Product Code: MQB Regulation Number: 892.1650 Device: Solid state x-ray imager (flat panel/digital imager)
FEB 2 7 2007
1 of 2
1
Tab 1 - Cover Letter Traditional 510(k)
Consultation with FDA Branch Chief. Team Leader or Designate
Andre Routh, the BSI Technical Reviewer, spoke with Dr. Robert Phillips (Supervisory Physicist, DHHS/ FDA/ CDRH/ ODE/ DRARD/ RDB) on January 25, 2007 to identify relevant issues and review criteria. Dr. Routh had previously sent an email introducing himself and the VIDAR Vision 2000 system (January 22, 2007). During the discussion, Dr. Phillips suggested that VIDAR request a letter from IMIX (Tampere, Finland) permitting VIDAR to include by reference the data submitted by IMIX to FDA in K974863. Unfortunately, the agreement between VIDAR and IMIX did not extend to the exchange of such information so the present submission follows the Traditional 510(k) format.
BSI Recommendation Regarding Substantial Equivalence:
The VIDAR VISION 2000 is currently manufactured by IMIX-ADR( Tampere, Finland) under the Premarket Notification of the predicate device (K974863). VIDAR intends to market this device under its own name. The device is physically and electrically (including software) identical to the predicate.
The labeling for the subject device has been reviewed to verify that the indication/intended use for the device is unaffected.
Based on the evidence supplied by the submitter, I recommend the device be determined substantially equivalent to the previously cleared device.
BSI Authorized Person
Signature:
John Howlett, Head of BSI Medical Device Notified Body
Date: February/22/2007
(Month/dd/yyy)
BSI Technical Reviewer
Signature: Andrei C. Rindt
Andre G. Routh, PhD, Senior Product Expert
Date: Feb 14, 2007
(Month/dd/yyyy)
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
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
Vidar Systems Corporation % Mr. John Howlett British Standards Institution Product Services Maylands Avenue HEMEL HEMSTEAD HP2 4SQ UNITED KINGDOM
AUG 2 3 2013
Re: K070563
Trade/Device Name: VIDAR Vision 2000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 14, 2007 Received: February 27, 2007
Dear Mr. Howlett:
This letter corrects our substantially equivalent letter of March 16, 2007.
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
3
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):___K070563
Device Name:___VIDAR Vision 2000
Indications For Use:
"The VIDAR Vision 2000 is indicated for use in generating radiographic images of human anatomy. It is a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures.
The VIDAR Vision 2000 is not indicated for diagnostic X-ray mammography."
Prescription Use × (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 Device Evaluation (ODE)
Nancy C. Hogdon
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070563