APOLLO

K050190 · Villa Sistemi Medicali S.P.A. · KXJ · Mar 25, 2005 · Radiology

Device Facts

• Record ID: K050190
• Device Name: APOLLO
• Applicant: Villa Sistemi Medicali S.P.A.
• Product Code: KXJ · Radiology
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1980
• Device Class: Class 2

Intended Use

The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.

Device Story

APOLLO is a remote-controlled radiology and fluoroscopy table system. It functions as a platform for patient positioning during X-ray procedures. The device includes a motorized table with tilt capabilities (-90° to +90°), a spot film device for capturing images, and a collimator for X-ray beam limitation. It is operated by clinicians in a radiology suite. The system supports various patient orientations and movements, including longitudinal and lateral scanning, while the patient remains stationary. It integrates with external X-ray generators, tubes, and image intensifiers to facilitate diagnostic imaging. The device provides mechanical support and precise positioning to enable high-quality radiographic and fluoroscopic image acquisition, aiding clinicians in diagnostic decision-making.

Clinical Evidence

bench testing only

Technological Characteristics

Remote-controlled R/F table; materials include plastic laminate or carbon fiber table top; motorized table tilt (-90° to +90°); motorized compressor; spot film device supports cassette sizes 13x18cm to 35x43cm; collimator with square/rectangular/iris options; grid is parkable; tomography movement (arc-plan); connectivity via integration with external X-ray generators and image acquisition systems.

Indications for Use

Indicated for radiology and fluoroscopy investigations in patients requiring diagnostic imaging, when used with compatible image intensifiers, acquisition systems, generators, and X-ray tubes.

Regulatory Classification

Identification

A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

Predicate Devices

• Philips Medical Systems OMNIDIAGNOST ELEVA (K032046)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for Villa Sistemi Medicali. The logo features a stylized letter 'V' above the company name. The text 'VILLA' is in a larger font size than 'SISTEMI MEDICALI', which is stacked below it.

MAR 2 5 2005

# Koso190

### Attachment 1 - 510 (k) SUMMARY

## 510(k) summary for APOLLO

#### Identification

| Applicant | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan- Italy<br>Registration Number: 8021091 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | + 39 02 48859233 |
| Designated Agent<br>in the US | Veronica Meredith<br>Del Medical Imaging<br>11550 West King Street<br>Franklin Park<br>Illinois 60131<br>Tel. [phone] |
| Manufacturing site | Villa Sistemi Medicali S.p.A.<br>Via delle Azalee 3,<br>20090 BUCCINASCO - Milan - Italy |

Trade name: APOLLO

Common name: APOLLO R/F remote controlled table

#### Classification:

The equipment is classified as a class II device since it is composed of the following three components:

radiological table (CFR892.1980): class I

spot film device (CFR892.1670): class II

X-ray beam limiting device (CFR 892-1610): class II

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### 150190

Substantial equivalent device: the APOLLO is defined as Substantially Equivalent (SE) to the Philips Medical Systems OMNIDIAGNOST ELEVA, manufactured by Philips Medical Systems and cleared by FDA with K032046

The following table compares the APOLI.O and the predicate device

| | APOLLO | Philips Omnidiagnost Eleva |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Remote controlled radiology<br>table, collimator and spot film<br>device | Remote controlled radiology<br>system inclusive of remote<br>controlled table, collimator,<br>spot film device, image<br>intensifier system |
| Working height (table<br>top center to<br>floorplate) | 600 -1400 mm | 840 -1140 mm |
| Table tilt movement | -90° - +90° | -90° - +90° |
| Table tilt speed | 4.5 -6.5°/sec | Variable 2-4.5°/sec |
| Table top suspension | Two sides suspension | Single side (left or right) |
| Table top material | 2379x750 Plastic laminate or<br>carbon fiber | 2250 x 660 mm carbon fiber |
| Table top movement | Patient remain stationary<br>during all scan movments | Patient remain stationary<br>during all scan movments |
| Table top absorption | Plastic:<0.5mm Al<br>Carbon fiber: <0.3 mm Al<br>@ 100kV, HVL 2.7mm Al | <= 1.1 mm Al eq. |
| Shape | Curved for max patient<br>comfort and autocentering | Curved for max patient<br>comfort and autocentering |
| Max patient weight | 150 kg | 200kg |
| Skin to film distance | 65 mm | 105 mm |
| Lateral scan distance | -160 - +160 mm | -160 - +160 mm |
| Lateral scan speed | 30 mm/sec | Variable 10 - 50 mm/sec |
| Longitudinal scan<br>distance | 1600 mm | 1550 mm |
| Longitudinal scan<br>speed | 30 - 200 mm/sec | Variable 20-120 mm/sec |
| Table column<br>angulation | -40° - +40° | -40° - +40° |
| Table column<br>angulation speed | 11.2 °/sec | Variable 4°-8°/sec |
| Source image distance | Continuous variable between<br>1000 and 1500 mm | Continuous variable between<br>1100 and 1500 mm |
| Tube rotation | Manual +/-180° with stops at | Manual -90° - +180° with |
| | 0°:+/-40°:+/-50°;+/-90°; 180° | stops at 0°-40°-90° |
| Image intensifier lift | 32 mm in 0.8 sec | 32 mm in 0.8 sec |
| Collimator | Square/rectangular.<br>Iris optional | Square/rectangular and Iris |
| Compressor movement | Motorized and parkable | Motorized and parkable |
| Compressor pressure | Adjustable between 30 and<br>150 N in steps of 5 N | Adjustable between 40 and<br>160 N |
| Automatic spot film<br>device | | |
| Cassette size | From 13x18cm to 35x43 | From 20x20 to 35x43 |
| Sudivisions | 1, 2, 3, 4 in line<br>4, 6 in cross | 1, 2, 3. 4 in line<br>4, 6 in cross |
| Load unload time | 2 sec | 2 sec |
| Preparation time for<br>exposure | 0.8 sec (min) | 1.2 sec |
| Rapid sequence | yes | 6 exposure in 4 sec |
| Grid | parkable | parkable |
| Tomography | | |
| Movement | Arc- plan motion: at 45°, 30°,<br>20°, 7° | Linear at 40°, 20° or 8° |
| Layer height range | 0 - 300 mm with automatic<br>layer height increments | 10 - 250 with automatic layer<br>height increments |
| Sweep time | 2 sec:<br>4 0 or 2.5 sec at 45°<br>2.7 or 1.3 sec at 30°<br>1.8 or 0.9 sec at 20°<br>0.6 Or 0.3 sec at 7° | 2 speeds:<br>3 0 or 1.5 sec at 40°<br>1.5 or 0.75 sec at 20°<br>0.6 or 0.3 sec at 8° |

510(K) Summary for APOLLO

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K050130

#### Indication for use.

The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, on the right side. On the left side, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2005

Villa Sistemi Medicali S.p.A. % Ms. Veronica Meridith Official Correspondent Del Medical Imaging 11550 West King Street FRANKLIN PARK IL 60131 Re: K050190

Trade/Device Name: APOLLO Regulation Number: 21 CFR 892.1980 Regulation Name: Radiologic table Regulation Number: 21 CFR 892.1670 Regulation Name: Spot-film device Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: KXJ, IXL, and KPW Dated: January 25, 2005 Received: February 10, 2005

Dear Ms. Meridith:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms tetter wrification. 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 n Joan t 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 premarket notification" (21 CFR 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/industry/support/index.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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K050190

#### Indication for use Statement 5.1.

510(k) Number:

Device Name: APOLLO

The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.

*Prescription Use*

Nancy C. Broodon

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