INTRAOS 70

K031118 · Blue X Imaging Srl · EHD · Jul 8, 2003 · Dental

Device Facts

• Record ID: K031118
• Device Name: INTRAOS 70
• Applicant: Blue X Imaging Srl
• Product Code: EHD · Dental
• Decision Date: Jul 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The IntraOs 70 (with Autoset Timer) is intended for the dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth. Such a device makes use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.

Device Story

IntraOs 70 is a dental X-ray generator for intraoral imaging; produces 70 kVp X-ray beam via circular cone (20cm source-skin distance, 6cm diameter field). Operated by dental professionals in clinical settings; features microprocessor-controlled exposure times (60ms to 3.2s) for repeatability. Includes remote-mountable timer and hand switch. System compensates for line voltage fluctuations via software algorithm. Provides high-quality film imaging; aids diagnosis of dental diseases. Tubehead weighs 6.4 kg; configurable mounting arms.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental X-ray generator; 70 kVp output; 7 mA tube current; single-phase, self-rectifying H.V. type. Microprocessor-controlled exposure timing (60ms-3.2s). Beam-limiting circular cone (20cm SSD, 6cm field). Tube inserts: OCX 70-G or RF8G070. Features automatic line voltage fluctuation compensation via software. Safety: dead man command, backup timer. Signaling: acoustic and visual.

Indications for Use

Indicated for dental radiographic examination and diagnosis of diseases of the teeth in patients requiring intraoral imaging.

Regulatory Classification

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.

Predicate Devices

• Explor-X 70

Submission Summary (Full Text)

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K031118

## Annex 1- 510(k) Summary for IntraOs 70

JUL 0 8 2003

.

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Kenny

| Date: | March 18, 2003 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Applicant | Blue X Imaging Srl. |
| | Via Idiomi 3/16 |
| | 20090 Assago -- Milan - Italy |
| | Phone: + 39-0245712171 |
| | Fax: + 39-0246703385 |
| Contact Person | Giuseppe Giacomini - CEO & |
| | General Manager |
| Device Name: | IntraOs 70 |
| Common Name: | X-Ray |
| Classification Name: | Unit, X-Ray, Extraoral |
| Legally Marketed device to which | Explor-X 70 |
| firm is claiming equivalence: | |
| Description of the Device: | IntraOs 70 is a Dental X-Ray |
| | generator; its primary use is for |
| | intra oral image receptor radiology. |
| | For such application, a peak voltage |
| | of $70 kV_p$ has been demonstrated to |
| | give a high quality film with a good |
| | film quality/risk ratio. |
| | |
| | The beam-limiting device is formed |
| | by a circular cone, which grants a |
| | source skin distance of 20cm and |
| | has a round output field of 6cm |
| | diameter. The weight of the |
| | tubehead is 6.4 kg. The certified |
| | components may be assembled in |
| | different configurations in terms of |
| | arms and mounting. |
| | |
| | Exposure times are microprocessor |
| | controlled, assuring a high |
| | constancy and also repeatability. |
| | The operator may choose exposure |
| | times from 60 ms to 3,2 s by object |
| | selection. Manual setting |
| | possibility or exposure time from |
| | 60 ms to 3,2 s (plus or minus, 18 |
| | steps: 0.06; 0.08; 0.10; 0.12; 0.16; |
| | 0.20; 0.25; 0.32; 0.40; 0.50; 0.64; |
| | 0.80; 1.00; 1.25; 1.60; 2.00; 2.50; |
| | 3.20 s) if required. |
| Intended use of the device: | Timer and hand switch can be remotely mounted. The hand-switch is provided with a 3 m-coiled cord. |
| | IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. |

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Summary of the Technological characteristics of IntraOs 70 compared to the predicate device Explor-X 70

| | Explor-X 70 | IntraOs 70 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Extra oral source X-<br>ray system for<br>dental radiographic<br>examination and<br>diagnosis of diseases<br>of the teeth | Extra oral source X-<br>ray system for<br>dental radiographic<br>examination and<br>diagnosis of diseases<br>of the teeth |
| High Voltage value | 70 kVp | 70 kVp |
| Tube current | 8 mA | 7mA |
| Tube insert | CEI OCX 70-G | OCX 70-G /<br>RF8G070 |
| H.V. type: | Single phase, self<br>rectifying | Single phase, self<br>rectifying |
| X-Ray exposure<br>time control | Microprocessor<br>Controlled | Microprocessor<br>Controlled |
| Compensation of<br>Line Voltage<br>Fluctuations | Yes, automatically<br>by software<br>algorithm | Yes, automatically<br>by software<br>algorithm.<br>This function can<br>optionally be<br>activated during<br>installation. |
| Safety features | Dead man command<br>Safety backup timer | Dead man command<br>Safety backup timer |
| Signaling devices | Acoustic and visual<br>signal<br>Optional remote<br>signaling | Acoustic and visual<br>signal<br>Optional remote<br>signaling |

The main differences of the IntraOs 70 with respect to SE device are mainly aesthetics; the functionality and technology are similar.

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing left. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 8 2003

Blue X Imaging Srl. % Mr. Al Sosa President Chicago X-Ray Systems, Inc. 251 E. Dundee Road Suite #6 WHEELING IL 60090

Re: K031118

Trade/Device Name: IntraOs 70 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: 90 EHD Dated: March 18, 2003 Received: April 9, 2003

Dear Mr. Sosa:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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510 (k) NUMBER (if KNOWN): DEVICE NAME: IntraOS 70 INDICATIONS FOR USE:

K 031118

The IntraOs 70 (with Autoset Timer) is intended for the dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth. Such a device makes use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div>✓</div> | OR | Over-The-Counter-Use<br>(Optional Formay 1-2-96) |
|------------------------------------------|--------------|----|--------------------------------------------------|
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| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | N031118 |