(63 days)
Explor-X 70 with Diamatic AP timer
Explor-X 70 with Diamatic AP timer
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
The device is described as an x-ray system intended for examination and diagnosis, not for treating diseases, which is the primary function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states the device is "intended for the dental radiologic application examination and diagnosis of deseases." The term "diagnosis" directly indicates a diagnostic purpose.
No
The device description explicitly states "Explor-X 70 with AP Time X timer," indicating a hardware component (the x-ray system and timer) is part of the device. The summary does not suggest the submission is solely for software controlling existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dental radiologic application examination and diagnosis of diseases related to the single use of an extra oral source x-ray system". This describes an in vivo diagnostic process (examining a living patient directly with radiation), not an in vitro process (examining samples outside the body).
- Device Description: The device is an "Explor-X 70 with AP Time X timer", which is an X-ray system. X-ray systems are used for imaging the inside of the body, not for testing biological samples.
- Input Imaging Modality: The input is "x-ray", which is an imaging modality used on living subjects.
- Anatomical Site: The anatomical site is "dental", referring to the teeth and surrounding structures within a living patient.
IVD devices are used to examine specimens such as blood, urine, or tissue samples outside of the body to provide information for diagnosis, monitoring, or screening. This device clearly operates on the patient directly.
N/A
Intended Use / Indications for Use
The Explor X 70 AP TIME X (the Explor X 70 with the AP TIME X timer) is intended for the dental radiographic examination and diagnosis of diseases related to the single use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.
Product codes
90 EHD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Explor-X 70 with Diamatic AP timer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a logo for Villa Sistemi Medicali. The logo consists of a stylized letter "V" above the words "VILLA" and "SISTEMI MEDICALI", which are stacked on top of each other. The logo is in black and white, with the letter "V" and the text being white against a black background.
K 991310
Annex 1 - 510 (k) SUMMARY
510(k) summary for Explor-X 70
Identification
| Applicant | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan- Italy |
|-------------------------------|------------------------------------------------------------------------------------------|
| Contact Person | dr. Francesco Attuati |
| Telephone (applicant) | + 39 2 488591 |
| Official Correspondent | Chicago X-Ray Systems, Inc.
Wheeling, IL 60090 |
| Contact Person | Al SOSA - President |
| Telephone
(contact person) | 847 - 459 3889 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan - Italy |
Trade name: Explor-X 70
Common name: Explor-X 70 with AP Time X timer
Classification name: according to 21 CFR 872-1800, Explor-X 70 device is in Class II.
Substantial equivalent device: the proposed equipment is defined as Substantially Equivalent (SE) to the Explor-X 70 with Diamatic AP timer. This assumption is based on the comparison table contained on the following page.
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 18 1999
Villa Sistemi Medicali S.P.A. C/o Chicago X-Ray Systems, Inc. Attn: Al Sosa 251 E. Dundee Road Wheeling, IL 60090
Re:
510(k) 991310 Trade Name: Explor-X-70 with AP Time X timer Dated: February 23, 1999 Received: April 16, 1999. Classification: II 21CFR 872.1800 Product Code: 90 EHD
Dear Mr.Sosa:
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 reclassified 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 (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 vertly 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 requlation 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/dsma/dsmamain.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
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| CC: | HFZ-401 | DMC |
|---|---|---|
| HFZ-404 | 510(k) Staff | |
| HFZ-D.O. | Division |
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510(k) NUMBER (IF KNOWN): K991310 DEVICE NAME: EXPLOR X 70 AP TIME X INDICATIONS FOR USE:
The Explor X 70 AP TIME X (the Explor X 70 with the AP TIME X timer) is intended The Explor A 70 AC THIO II (Miassion and diagnosis of deseases related to the for the demail rablog applie exammistion and singless use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.
(PLEASE DO NOT WRITE BELOW - CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-The-Counter-Use |
| (Per 21 CFR 801.109) ✓ | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K991310 |