THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)

K052422 · Flow X-Ray Corp. · EAP · Sep 27, 2005 · Dental

Device Facts

• Record ID: K052422
• Device Name: THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
• Applicant: Flow X-Ray Corp.
• Product Code: EAP · Dental
• Decision Date: Sep 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1810
• Device Class: Class 2

Intended 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.

Device Story

EnVision Intraoral Dental X-Ray Machine (wall-mounted or mobile) generates X-ray radiation for dental imaging. Device produces constant-potential output; includes integrated and remote versions; compatible with various line voltages; supports 30 cm round and optional rectangular source-to-skin distances (SSDs). Modification adds preset anatomical manual exposure time settings to minimize operator selection errors for different tooth types, patient sizes, and receptor speeds. Operated by trained dental professionals in clinical settings. Output is used for diagnostic visualization of dental anatomy. Benefits include improved efficiency and reduced potential for exposure errors.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and software validation.

Technological Characteristics

Intraoral X-ray system; constant-potential output; wall-mounted or mobile form factor. Compliance with IEC 60601-1 and ISO 14971:2000. Features preset anatomical manual exposure time settings. Connectivity/software details not specified beyond system control.

Indications for Use

Indicated for intraoral radiography of dental anatomy for diagnostic purposes. For use by professionally trained and licensed personnel.

Regulatory Classification

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.

Predicate Devices

• MDT/Castle Model HDX Dental X-Ray Machine (K896024)

Submission Summary (Full Text)

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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: [phone]

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

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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

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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.

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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.

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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 [phone] or [phone] 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

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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