FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50

K061361 · Faxitron X-Ray Corp. · MWP · Aug 15, 2006 · Radiology

Device Facts

• Record ID: K061361
• Device Name: FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
• Applicant: Faxitron X-Ray Corp.
• Product Code: MWP · Radiology
• Decision Date: Aug 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The DX-50 is a Cabinet x-ray system that is used to provide digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

Device Story

Cabinet x-ray system for specimen radiography; provides digital images of harvested tissue samples. Used in clinical settings (OR or nearby) by healthcare professionals to verify biopsy excision success. Enables rapid verification; reduces patient time under examination; potentially limits patient recalls. Input: harvested anatomical specimens. Output: digital x-ray images for clinician review. Clinical decision-making: confirms correct tissue excision during biopsy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cabinet x-ray system; stationary x-ray system (21 CFR 892.1680); digital radiography imaging; product code MWP.

Indications for Use

Indicated for rapid verification of excised tissue specimens during biopsy procedures to confirm correct tissue removal.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Mr. Douglas C. Wiegman VP Engineering Faxitron X-ray Corporation 225 Larkin Drive, Suite 1 WHEELING IL 60090-7209

Re: K061361

Trade/Device Name: Dx-50 Digital Radiography System Regulation Number: 21 CFR 892 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: July 26, 2006 Received: July 27, 2006

Dear Mr. Wiegman:

This letter corrects our substantially equivalent letter of August 15, 2006.

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 (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

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ling Public . Health

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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 continue 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 [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 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,

Javid G. Lozano

Nancy C. Brogg Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(K) Number (if known):

Kob1361

Device Name: DX-50 Digital Radiography System

Indications for Use: The DX-50 is a Cabinet x-ray system that is used to provide digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

Prescription Use
(Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(Per 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)

Dancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061361

Faxitron X-ray Corporation

DX-50 510(k) Submission