MOVABLE ADD-ON COUCH FOR OUTLOOK

K960973 · Philips Medical Systems (Cleveland), Inc. · LNH · May 29, 1996 · Radiology

Device Facts

• Record ID: K960973
• Device Name: MOVABLE ADD-ON COUCH FOR OUTLOOK
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: May 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Movable Add-on Couch is designed to be used with the Outlook MRI system and in an X-Ray environment. The indications for use are the same as for standard MR imaging.

Device Story

Movable Add-on Couch interfaces with Outlook MRI system; enables patient transfer on upper couch plate to/from movable base; eliminates need to lift patient during transport between MRI and X-ray modalities. Upper couch plate features radio-translucent material for fluoroscopic examinations via X-ray C-arm. Operated by clinical staff in MRI/X-ray suites. Benefits include reduced patient handling, improved workflow efficiency, and continuous support during multi-modality imaging.

Clinical Evidence

No clinical data. Bench testing only, focusing on mechanical specifications, weight capacity, and X-ray absorption equivalence.

Technological Characteristics

Upper couch plate: sandwiched bakelite/PVC-foam. Movable base: bakelite (X-ray transparent) and aluminum (load-carrying). Dimensions: 2400mm length, 625mm width. Movement: manual horizontal, motorized battery-powered vertical. X-ray absorption: ≤ 1.5 mm aluminum equivalent.

Indications for Use

Indicated for patients undergoing standard MR imaging and fluoroscopic X-ray examinations requiring patient transport between modalities.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device 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

• Outlook standard couch (K945827)
• NRF X-Ray Table (K944973)

Submission Summary (Full Text)

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K960973

# SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. General Information

**MAY 29 1996**

**Classification:**
Class II
Magnetic Resonance (MR) Imaging System

**Common/Usual Name:**
MRI Patient Couch

**Proprietary Name:**
Movable Add-on Couch for Outlook

**Establishment Registration:**

**Manufacturer:**
Picker Nordstar, Inc.
P.O. Box 33
FIN-0051 Helsinki, FINLAND
Phone: [phone]
Fax: [phone]
FDA Facility Registration #9680194

**United States Representative:**
Picker International, Inc.
595 Miner Road
Cleveland, OH 44143
FDA Owner Number #1580240

**Performance Standards:**

No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act. The device and its labeling comply with the following applicable requirements.

Code of Federal Regulations Title 21, Subchapter J - Radiological Health, applicable sections which include:

| 1020.30(c) | Certification of components |
| --- | --- |
| 1020.30(e) | Identification of X-ray components |
| 1020.30(g) | Information for assemblers |
| 1020.30(h) | Information for users |
| 1020.30(n) | Aluminum equivalent of material |
| 1020.31(3)(1)(i) | Beam axis perpendicularity to image receptor and SID |

PICKER INTERNATIONAL, INC. (MCO) (3/7/96) I-1

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# 2. Intended Uses

The Movable Add-on Couch is designed to be used with the Outlook MRI system and in an X-Ray environment. The indications for use are the same as for standard MR imaging.

# 3. Device Description

The Movable Add-on couch augments the patient handling capabilities of the Outlook MRI system. It interfaces directly with the Outlook patient couch.

The Movable Add-on Couch enables transfer of the patient together with the upper couch plate to and from a movable base directly into the Outlook patient handling system. This makes it possible to do MR imaging without having to lift patient from the supporting surface. The patient can be transported to other imaging modalities using the movable base.

The movable couch also has a radio-translucent upper part making it possible to do fluoroscopic examinations, e.g. with an X-Ray C-arm system, of the patient while on the couch.

The upper couch plate is made of sandwiched bakelite/PVC-foam material. The movable base has two parts; the X-Ray transparent part made of bakelite and the load-carrying parts and coMwrs made of aluminum.

# 4. Safety and Effectiveness

SUBSTANTIAL EQUIVALENCE CHART

| PARAMETER | MOVABLE ADD-ON COUCH FOR OUTLOOK | PREDICATE |
| --- | --- | --- |
| Length | 2400 mm | 2400 mm |
| Width of couch plate | 625 mm (+ handle 55mm) | 625 mm |
| Height to the edge of the couch | 880 mm (upper position) | 880 mm
(Outlook standard couch K945827) |
| Portable | yes | no (Outlook standard couch K945827) |

PICKER INTERNATIONAL, INC. (MCO) (3/7/96)

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| PARAMETER | MOVABLE ADD-ON COUCH FOR OUTLOOK | PREDICATE |
| --- | --- | --- |
| Maximum patient weight | 200 kg | 200 kg (Outlook standard couch K945827) |
| Movement, horizontal | manual | manual (Outlook standard couch K945827) |
| Movement, vertical | motorized, battery powered | no (Outlook standard couch K945827) |
| X-Ray Absorption | equal to or below 1.5 mm aluminum | rejection limit 1.2 mm (NRF X-Ray Table K944973) |
| Intended for Use | MR and X-Ray examinations; movable | MR examinations; stationary (Outlook standard couch K945827) |

PICKER INTERNATIONAL, INC. (MCO) (3/8/96)