ZIEHM QUANTUM

K051064 · Ziehm Imaging, Inc. · OWB · May 26, 2005 · Radiology

Device Facts

• Record ID: K051064
• Device Name: ZIEHM QUANTUM
• Applicant: Ziehm Imaging, Inc.
• Product Code: OWB · Radiology
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic imaging for a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures include Cerebral, Thoracic, Vascular, Abdominal, Orthopaedic, Peripheral, Embolization, Stent Placement, Urological, Special Vascular-Flow Procedures, and other related fluoroscopic examinations requiring interventional procedures. The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures. Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Device Story

Mobile C-arm X-ray system; provides real-time fluoroscopic and radiographic imaging for surgical guidance and interventional procedures. Operates by generating X-rays directed at a patient, captured by an image intensifier; supports accessory cassette for film radiography. Used by physicians and clinical staff in operating rooms or clinical settings. Output displayed on monitors for real-time visualization of anatomy and interventional tools (e.g., stents, catheters). Facilitates minimally invasive procedures, improves procedural accuracy, and reduces need for fixed-room imaging.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mobile C-arm X-ray system; image-intensified fluoroscopy; radiographic capability via accessory cassette. Operates as a mobile unit for intraoperative imaging. Complies with 21 CFR 1000-1050 electronic product radiation control provisions.

Indications for Use

Indicated for patients requiring radiographic or fluoroscopic imaging during surgical, interventional, or guidance procedures, including cerebral, thoracic, vascular, abdominal, orthopaedic, peripheral, urological, embolization, and stent placement procedures. Suitable for use in or out of the operating room and as a backup for fixed-based X-ray systems.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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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## MAY 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Westrich VP Product Development and Regulatory Affairs Ziehm Imaging, Inc. 4181 Latham Street RIVERSIDE CA 92501

Re: K051064

Trade/Device Name: ZIEHM QUANTUM (Mobile x-ray system) Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: April 26, 2005 Received: April 26, 2005

Dear Mr. Westrich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have rowled your coothe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholors, to e 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 do not require approvisions of the Act. The general controls provisions provisions of the Act de receiver to the general 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 (Premarket n your av, it may be subject to such additional controls. Existing major regulations affecting your Apployally, it they of below to 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 I Rase oc advisou that 1971 ion 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 I cacal statues and rogalized to registration and listing (21 CFR Part 807); labeling Act 3 requirements, morating practice requirements 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 5 IC(k) This letter will allow you to begin marketing your antil equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your d premarket notification. The FDA miding of subsantial organities of the promits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased If you desire specific advice for your device on our laboring organism (
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 prematice notification" (21 CFR Also, please note the regulation entitled, "thisorians of our responsibilities under the Act from the Act from the 807.97). You may obtain other general international at its oll-free number (800)
Division of Small Manufacturers, International and Consumers assuccessfor the Division of Small Manufacturers, International and Octoberts Internet and Products/dsmaldsmamain.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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## Indication of Use Statement

| Applicant: | Ziehm Imaging, Inc.<br>4181 Latham Street<br>Riverside CA. 92501 |
|----------------|------------------------------------------------------------------|
| 510(k) Number: | K051064 |
| Device Name: | ZIEHM QUANTUM<br>(Mobile x-ray system) |

## Indications for Use:

The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic The ZIEFIN QUANT Only seller no wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures requiring X-ray maging overy; Abdominal, Orthopacdic, Peripheral, include Celebral, Thoracio, Vasoura Bagory, Emolization, Stent Placement, Urological Special Vascular-I fow Frocedures, and other related fluoroscopic examinations requiring interventional procedures.

The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

*Prescription Use*

Nancye Bagdon

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