SIREMOBIL ISO-C 3D

K040347 · Siemens Medical Systems, Inc. · OXO · Mar 9, 2004 · Radiology

Device Facts

• Record ID: K040347
• Device Name: SIREMOBIL ISO-C 3D
• Applicant: Siemens Medical Systems, Inc.
• Product Code: OXO · Radiology
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.

Device Story

Mobile isocentric C-arm X-ray system; includes high-frequency generator, X-ray tube, image intensifier, TV camera, and digital memory/monitor trolley. Captures series of 2D X-ray images; reconstructs into 3D image format. Used intraoperatively by physicians to visualize high-contrast objects and anatomical structures. Provides real-time 3D information to guide surgical decision-making and improve procedural outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Isocentric mobile C-arm; high-frequency X-ray generator; image intensifier; TV camera; digital memory device; laser light localizers. 3D reconstruction software. Class II device.

Indications for Use

Indicated for intraoperative 3D imaging of high contrast objects and anatomical structures throughout the entire body to assist physicians during surgical procedures.

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 Iso-C 3D (K032088)

Submission Summary (Full Text)

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## K040347

MAR - 9 2004

510(K) SUMMARY FOR THE SIREMOBIL ISO-C 3D

Submitted by:

Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvem, PA 19355

February 10, 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.

#### 1. Contact Person:

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

#### Device Name and Classification: 2.

| Trade Name: | Siremobil Iso-C 3D |
|------------------------|---------------------|
| Classification Name: | Mobile X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1720 |
| Device Classification: | Class II |
| Product Code: | DXO, JAA |

#### Substantial: Equivalence: 3.

The Siremobil Iso-C 3D is designed for three-dimensional evaluation of data acquired with an isocentric mobile C-arm device. The package is substantially equivalent to the following devices:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|----------------------------|----------------------|--------------------|
| Siemens Siremobil Iso-C 3D | K032088 | 09/10/03 |

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#### 4. Device Description:

# 1040347

The Sirernobil Iso-C 3D is an isocentric mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The 3D imaging option allows the reconstruction of two-dimensional images acquired with a mobile isocentric C-arm device into a three-dimensional image format.

#### Intended Use of the Device: ડ.

The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.

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

The Siemens Siremobil Iso-C 3D with extended Indications for Use and the predicate devices allow reconstruction of a three-dimensional model from a scries of two dimensional images acquired with a C-arm imaging device.

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

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

MAY 22 2012

Re: K040347

Trade/Device Name: Siremobil ISO-C 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO and JAA Dated: February 10, 2004 Received: February 12, 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 medical device-related adverse cromb) (ystems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket will anow you to begal manitoling your antial equivalence of your device to a legally marketed notheation. The I Drivening of succion 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 II you desire specific advice for your avrous ic Device Evaluation and Safety at (301) 796-607), prodoc conceent and 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 I ou may other only 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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KOYO347 510(k) Number (if known): Device Name: Siremobil Iso-C 3D

### Indications For Use:

The Siremobil Iso-C 3D with extended Indications for Use is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C 3D. The extended Indications for Use include the high contrast objects and anatomical structures of the entire body. The Siremobil Iso-C 3D contains no new hardware or software.

The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.

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

| Prescription Use | <div> OR Over-The-Counter Use </div> <div> (Per 21 CFR 801.109) </div> |
|------------------|--------------------------------------------------------------------------------------------------------------------------------|
|------------------|--------------------------------------------------------------------------------------------------------------------------------|

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | k040347 |
|---------------|---------|
|---------------|---------|

Simplified 510(k) for Siemens Medical Solution Siremobil Iso-C 3D