SIREMOBILE C06

K040066 · Siemens Medical Solutions USA, Inc. · OXO · Feb 12, 2004 · Radiology

Device Facts

• Record ID: K040066
• Device Name: SIREMOBILE C06
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OXO · Radiology
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Siremobil C06 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil 06 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clivical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Device Story

Mobile C-arm X-ray system; includes high-frequency generator, X-ray tube, image intensifier, TV camera, film cassette attachment, laser target devices, and monitor trolley. Operates in digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping modes. Used in OR, trauma, endoscopy, ICU, and veterinary settings by clinicians. Inputs include X-ray radiation; outputs include real-time fluoroscopic or static radiographic images displayed on flat-screen monitors. Digital storage system manages image data. Uninterruptible power supply protects data during outages. Assists physicians in surgical guidance, implant positioning, and interventional procedures; improves clinical workflow and patient outcomes through real-time visualization.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mobile C-arm X-ray system. High-frequency generator, X-ray tube, image intensifier. 1024^2 digital image processing. Flat-screen monitors. Uninterruptible power supply. Modes: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, roadmapping. Footswitch/hand switch control.

Indications for Use

Indicated for patients requiring intraoperative imaging, including pediatric and ambulatory populations, for procedures such as bile duct display, intra-medullary nail implantation, pain therapy, and catheter/probe positioning.

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.

Predicate Devices

• Siemens Siremobil Compact (K963093)
• Siemens Siremobil Iso-C (K973598)

Reference Devices

• Uroskop Access

Submission Summary (Full Text)

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Kolooee

# FEB 1 2 2004

SIREMOBIL C 06 Submitted by:

510(K) SUMMARY

FOR THE

Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

January 13, 2004

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### Contact Person: 1.

Ms. Nealie Hartman 51 Valley Stream Parkway Malvern, PA 19355 Phone: [phone] Fax: [phone]

#### Device Name and Classification: 2.

Trade Name:

Classification Name: Classification Panel: CFR Section: Device Classification: Product Code:

Siremobil C 06 (C06 is internal project name, final name assignment will be determined prior to FDA clearance) Mobile X-Ray System Radiology 21 CFR §892.1720 Class II OYO & JAA

#### Substantial Equivalence: 3.

The Siremobil C 06 is substantially equivalent to the following devices:

| Predicate Device Name | 510(k) Number | Clearance Date | Comparable Properties |
|---------------------------|---------------|----------------|----------------------------------------------|
| Siemens Siremobil Compact | K963093 | 08/07/1996 | Hardware<br>Control Software<br>Intended use |
| Siemens Siremobil Iso-C | K973598 | 11/10/1997 | Hardware<br>Control Software<br>Intended use |

CONFIDENTIAI

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## Device Description: 4.

The Siremobil C 06 is a mobile x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassotte attachment, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitor(s), and user interface. The system is equipped with a footswitch and a hand switch for radiation release in the five modes of operation: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping.

### Intended Use of the Device: ર.

The Siremobil C06 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil 06 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clivical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

# Summary of Technological Characteristics of the Devices Compared to 6. the Predicate:

The Siremobil C 06 is a modification to the Siremobil Compact. Mechanically the changes are minor in design and style. The X-ray generator, X-ray tube and Image Intensifier are identical with the currently cleared product.

The imaging chain reflects the current standard of 10242 image processing and display with flat screen monitors. It was originally cleared with a stationary X-ray system (Uroskop Access) and is in clinical operation since more than 2 years. An uninterruntable power supply provides additional safety to image and demographic data in the event of a power outage.

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Ms. Nealie Hartman Technical Specialist Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway J-15 MALVERN PA 19355

MAY 22 2012

Re: K040066

Trade/Device Name: Siremobil CO6 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO and JAA Dated: January 13, 2004 Received: January 13, 2004

Dear Ms. Hartman:

This letter corrects our substantially equivalent letter of November 14, 2011.

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 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 Parts 801 and 809), please contact 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 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/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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INDICATIONS FOR USE

| 510(k) Number (if known): | K040060 |
|---------------------------|---------------|
| Device Name: | SIREMOBIL C06 |

Indications For Use:

The Siremobil C06 is a mobile x-ray system intended for use in operating room, The Strenoon Coo is a moone it ve care station, pediatrics, ambulatory patient traumathogy, cheosophy, interaction of can operate in six different care and in vetermaly, Fluoroscopy, Pulsed Fluoroscopy, Cassette modes. Digital Radiographysn, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct performing wide variety of of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

(Please do not write below this line - continue on another page if needed) ..............................................................................................................................................................................

Concurrence of the CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use_ Prescription Usc (Per 21 CFR 801.109)

David A. Lynn

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

Siemens Medical Solutions, Inc. USA Special 510(k) Siremobil C06

CONFIDENTIAL

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