(25 days)
K#896024
Not Found
No
The document describes a standard dental X-ray machine and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an X-Ray machine for diagnostic purposes, specifically for intraoral radiography of dental anatomy, and does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is for "diagnostic purposes."
No
The device description explicitly states it is an "Intraoral Dental X-Ray Machine" and describes it as a "Constant-potential radiation system," indicating it is a hardware device that produces X-rays.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The EnVision Intraoral Dental X-Ray Machine is used to produce images of dental anatomy within the body using X-rays. This is an in vivo diagnostic imaging device.
- Intended Use: The intended use clearly states "intraoral radiography of dental anatomy for diagnostic purposes." This involves taking images directly of the patient's teeth and surrounding structures.
Therefore, based on the provided information, the EnVision Intraoral Dental X-Ray Machine is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are intended to be used only for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.
Product codes (comma separated list FDA assigned to the subject device)
EAP
Device Description
The EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) is intended to be used for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use purposes.
The EnVision Intraoral Dental X-Ray Machine is a highly efficient user-friendly Constant-potential intraoral radiation system that produces, clear, sharp output x-ray images with minimal exposure time. Includes 2 versions- integrated and remote, that are compatible with various line voltages, and equipped with 8 and 12-inch (20 and 30 cm) round, and rectangular SSD's (Source to Skin Distance) available as optional).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Dental anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professionally trained and licensed personnel / 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)
Non-Clinical Test: Compliance to applicable voluntary standards includes IEC 60601-1 and IEC 60601-1-3 for Medical Electrical Equipment and Electromagnetic Compatibility, in addition, ISO 14971: 2000, "Medical Devices - Application of Risk Management to Medical Devices Standard" was used for our Risk Assessment.
Clinical Tests: Not Applicable
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.
K#896024
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
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Exhibit #2
SEP 2 7 2005
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in This Summary of Sickly Safety ents of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K052422
Submitter's Identification: 1.
Flow X-Ray Corporation 420 Hempstead Turnpike W. Hempstead, NY 11562 Tel: 516-485-7000
Contact: Mr. Peter Mitropoulos
Date Summary Prepared: August 31, 2005
Name of the Device: 2.
EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)
Common or Usual Name:
Intraoral Dental X-Ray Unit
Predicate Device Information: 3.
K#896024, MDT/Castle Model HDX Dental X-Ray Machine; MDT Diagnostic Co., Rochester, NY
Device Description: 4.
The EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) is intended to be used for intraoral radiography of dental anatomy for diagnostic intended to be acou for nr fessionally trained and licensed personnel on the use purposes porformously porte that the intended use of the EnVision Machine, as described in the labeling, has not changed as a result of the modification.
The reason for the modification is to minimize the potential error(s) an operator may make in selecting the desired x-ray exposure time(s) for different speed
1
image receptors, different teeth, different size patients, and different length cones.
The EnVision Intraoral Dental X-Ray Machine is a highly efficient user-friendly The Envision Intraoral Bontal liation system that produces, clear, sharp Constant-potchildi output A faciallex of sure time. Includes 2 versions- integrated fradiography with minimal Stapsed on various line voltages, and and remote, that are comigated to open to open to and the (30 cm round, and equipped with rectangular SSD's available as optional).
Intended Use: 5.
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are The Envision Intraoral radiography of dental anatomy of dental anatomy for intended to be assu only for intrass professionally trained and licensed personnel on the use of the system.
Comparison to Predicate Devices: 6.
The EnVision and HDX Dental X-Ray Machines (Wall Mounted and Mobile) are The ENVISION and HDA Donathe intended use and technology. In addition to virtually identioun'in rogard to the MDX, a new feature of preset anatomical manual exposure time settings had been added to the EnVision Machine to reduce the exposure time octings had beselecting the proper exposure time for different teeth.
Discussion of Non-Clinical Test Performed for Determination of 7. Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes IEC 60601-1 and IEC Compliano to applicable Totalition, ISO 14971: 2000, "Medical Devices -Application of Risk Management to Medical Devices Standard" was used for our Risk Assessment.
Discussion of Clinical Tests Performed: 8.
Not Applicable
Conclusions: 9.
The subject device, the EnVision Intraoral Dental X-Ray Machine (Wall Mounted The Subject Gevice, the Envisions for use as the original MDT/Castle Model HDX Dental X-Ray Machine. The bench testing and software validation documentation contained in our submission demonstrates that there are no
2
differences in their technological characteristics, thereby not raising any new differences in their lechnological J.Thus, the EnVision Intraoral Dental X-Ray Issues of Salety of enectiveneos. "This, the Envision in the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Flow X-Ray Corporation % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
Re: K052422
Trade/Device Name: EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) Regulation Number: 21 CFR 872.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP Dated: September 1, 2005 Received: September 2, 2005
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to make the device referenced in we have reviewed your Section 710(x) premaint invinced (for the indications for use stated in above and nave determined the do needicate devices marketed in interstate commerce prior to the enclosure) to legally maneted predical Device Amendments, or to devices that have been May 26, 1970, the chacinem and of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act that the reclassmed in accordaties with and proval application (PMA). You may, therefore, market the do not require approval of a premance approval special controls provisions of the Act. device, subject to the general connois provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see above) into entrols. Existing major regulations affecting your Approval), It may of subject to such adations, Title 21, Parts 800 to 898. In addition, FDA device can of found in the Obacents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEase be advised marr 271 s issumise of evice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administer of registration and listing (21 CFR Part 807); labeling Act s requirements, metading bactive minited to reguirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k)
1992) 1 This letter will allow you to begin harketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA initing of substantial of a loves 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), please
r the regulation of the for a tool on to the courshers, becad on the regul If you desire specific advice for your device on our labering regarities.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "visoranante" of your cases in the Act from the 807.97). You may obtain other gelleral information on your september Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit B
1 Page -
510(k) Number (if known): KD52422
Device Name: EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile)
Indications For Use:
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)
The EnVision Intractal in transal redications were anatomy The Envision Intraoral Dental >> R&F Machaeling of dental anatomy
are intended to be used only for intractal radiography topingd and licensed are intended to be used only for intrueral radiography f
for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.
Prescription Use _ X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-C Division of Reproduct 510(k) Numb