QUANTUM DIREX SYSTEM

K072010 · Quantum Medical Imaging, LLC · KPR · Aug 7, 2007 · Radiology

Device Facts

• Record ID: K072010
• Device Name: QUANTUM DIREX SYSTEM
• Applicant: Quantum Medical Imaging, LLC
• Product Code: KPR · Radiology
• Decision Date: Aug 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.

Device Story

Quantum DiRex System is an integrated digital radiographic imaging system; combines Quantum Q-Rad Radiographic System with Agfa DX-S CR System (digitizer and NX workstation). Device captures X-ray exposures of skeleton, chest, abdomen, and other body parts; produces diagnostic quality digital images. Used in clinical settings by healthcare professionals to aid physician diagnosis. System integrates previously cleared hardware components into a single marketed unit. Output allows clinicians to visualize internal anatomy for diagnostic decision-making; benefits patient through efficient digital radiographic assessment.

Clinical Evidence

Bench testing only. Performance data demonstrated substantial equivalence to predicate devices and adherence to predetermined acceptance criteria based on system design inputs. No clinical data or biocompatibility testing was required as all patient-contacting materials were previously cleared for similar devices.

Technological Characteristics

Stationary X-ray system; integrates radiographic hardware with digital CR digitizer and workstation. Materials are identical to previously cleared predicate devices. Connectivity via NX workstation. No specific software algorithm class or energy source details provided beyond standard radiographic operation.

Indications for Use

Indicated for patients requiring radiographic imaging of the skeleton (skull, spine, extremities), chest, abdomen, and other body parts for diagnostic purposes. 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

• Quantum Q-Rad Radiographic System (K011486)
• Agfa DX-S CR System (K053634)
• Agfa DX-Si System (K063421)
• Agfa CR85-X Digitizer (K062742)
• Agfa CR30-X (K062223)

Submission Summary (Full Text)

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# AUG - 7 2007

# Section 5 - 510(k) Summary

# General Information

| Owner's Name: | Quantum Medical Imaging, LLC |
|--------------------------|--------------------------------------------------------------------|
| Address: | 2002-B Orville Drive North |
| | Ronkonkoma, NY 11779-7661 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Mark Camirand; Director Q.A./Compliance |
| Subject Device Name: | Quantum DiRex System |
| Common/Usual Name: | Stationary Electrostatic X-Ray System |
| Product Codes: | LLZ; KPR; MQB |
| Regulation: | 21 CFR 892.2050 / 21 CFR 892.1680 / 21 CFR 892.1650 |
| Classification: | Class II |
| Predicate Device Names: | Quantum Q-Rad Radiographic System / Agfa DX-S CR System / Agfa DX- |
| | Si System / Agfa CR85-X Digitizer / Agfa CR30-X |
| Manufacturers: | Quantum Medical Imaging, LLC / Agfa Corp. |
| Premarket Notifications: | K011486 / K053634 / K063421 / K062742 / K062223 |

#### Device Description

The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Agfa DX-S CR System (digitizer with NX workstation). The Quantum DiRex System is a combination of these previously cleared systems that have been combined and will be marketed as a single system.

### Intended Use

The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts.

# Performance Testing

Performance data demonstrated that the Quantum DiRex System is substantially equivalent to the predicate devices and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by standardized risk/hazard analysis techniques. Performance testing was successfully completed on the proposed system in accordance with predetermined protocols based on the system design inputs.

No biocompatibility testing was conducted in support of this 510(k); all patient-contacting materials used in the manufacture of the DiRex System have been previously cleared for similar devices.

#### Technological Characteristics

The technological characteristics are the same in the proposed and predicate devices.

#### Conclusion

The Quantum DiRex System meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the DiRex System is substanially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Quantum Medical Imaging, LLC % Mr. Jeff Rongero Senior Project Engineer, Medical Business Unit Underwriters Laboratories, Inc. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709

Re: K072010

Trade/Device Name: Quantum DiRex System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: July 17, 2007 Received: July 23, 2007

AUG 2 1 2013

Dear Mr. Rongero:

This letter corrects our substantially equivalent letter of August 7, 2007.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 nredicate 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 Parts 801 and 11 you don't open and the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the To a may 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/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

510(k) Number (if known):

K072010

Device Name:

Quantum DiRex System

Indications for Use:

The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.

Prescription Use X (Per 21 CFR 801 Subpart D) 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)

Herbert Werner

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

10