INTUITION, MODEL 0170

K073632 · Arcoma AB · KPR · Jan 10, 2008 · Radiology

Device Facts

• Record ID: K073632
• Device Name: INTUITION, MODEL 0170
• Applicant: Arcoma AB
• Product Code: KPR · Radiology
• Decision Date: Jan 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The 0170 Intuition is not intended for mammography.

Device Story

Intuition Model 0170 is a stationary X-ray system for clinical radiographic imaging. System components include a ceiling-mounted tube stand, floor-mounted table, and wall stand with a detector holder. Ceiling stand and table feature automatic vertical movement; other movements are manual. Standard equipment includes a graphic display for monitoring X-ray tube rotation, film focus, and source-image distance. Operated by clinical staff in a clinical environment to acquire diagnostic images. Output is used by healthcare providers to assist in clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Stationary X-ray system. Components: ceiling-mounted tube stand, floor-mounted table, wall stand with detector holder. Features automatic vertical movement for table and tube stand. Includes graphic display for tube rotation and source-image distance monitoring. Manual movement for non-automatic axes.

Indications for Use

Indicated for obtaining radiographic images of various portions of the human body in a clinical environment. Not indicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Q-Rad Radiographic System (K011486)
• Xplorer 2200 Digital Radiographic System (K063039)
• DAR7000 RADspeed SAFIRE (K050925)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "ARCOMA" in a simple, sans-serif font. To the left of the word is a stylized logo consisting of three curved lines converging to form a triangular shape. The logo and the text are both in black and stand out against a white background.

K073632

JAN 10 2008

### 510 (k) Summery

Date of summery: November 26, 2007

#### Submitter/Manufacturer/Applicant:

Arcoma AB Annavagen 1 SE-352 46 Vaxio Sweden Contact person: Bengt-Hugo Johansson Phone: [phone] Fax: [phone]

#### Device Name and Classification

Trade name Classification name Review Panel Product Code Requlation Number Device classification Arcoma, Intuition Stationary x-ray system Radiology KPR 892.1680 Class II

#### Predicate device

- 1. Q-Rad Radiographic System manufactured by Quantum Medical Imaging LLC, K011486
- 2. Xplorer 2200 Digital Radiographic System manufactured by Imaging Dynamics Company Ltd, K063039
- 3. DAR7000 RADspeed SAFIRE manufactured by Shimadzu Corporation. K050925

#### Device description

The 0170 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and a wall stand that has a floor mounted column with a detector holder.

The ceiling stand and the table has automatic movements for up and downs, other movements are manual.

The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance.

#### Intended use

The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment.

The 0170 Intuition is not intended for mammography

ARCOMA AB Annavagen 1 SE-352 46 Växjo weden

Telefon/Phone :[phone] [e-mail]

Favitav -46 (0)470 70 69 99 5 - 1

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that represents the department's mission.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 10 2008

ARCOMA AB % Mr. Jay Y. Kogoma Official Correspondent Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K073632

Trade/Device Name: Intuition, Model 0170 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 21, 2007 Received: December 26, 2007

Dear Mr. Kogoma:

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 such 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.

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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.

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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/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

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# COMA

## Statement of Indication for Use

510(k) Number: K_073632

Device Name: Intuition, Model 0170

The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment.

The 0170 Intuition is not intended for mammography.

Prescription Use X (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)

tony K. Wh

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

4 - 1

ARCOMA AB Annavägen 1 SE-357 46 Växič SWATER

Telefon/Phone [phone] [e-mail]

46 (0)470 70 69 99