← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K964752 # KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER (K964752) _Philips Medical Systems (Cleveland), Inc. · LNH · Feb 24, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K964752 ## Device Facts - **Applicant:** Philips Medical Systems (Cleveland), Inc. - **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md) - **Decision Date:** Feb 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder. ## Device Story Kinematic positioning devices for Outlook MRI system; used to constrain patient anatomy (c-spine, knee, shoulder) in specific positions during imaging. C-spine device allows flexion, extension, lateral movement, and rotation. Knee device allows flexion and extension. Shoulder device allows abduction, adduction, and rotation. Devices include integrated holders for multipurpose receiver coils. Manually operated by clinician; no active components or motors. Enables physician to evaluate dynamic tissue interactions; aids in diagnostic interpretation of MRI images. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Non-ferromagnetic materials; manually operated mechanical positioning frames; integrated receiver coil holders; no active energy sources or motors; dimensions/form factor specific to anatomical region (c-spine, knee, shoulder). ## Regulatory 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 - Siemen's Kinematic Knee Device for the Magnetom Open System ([K961121](/device/K961121.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 216-473-5729 12:48 # FEB 24 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) ## 1. General Information K964752 Classification: Class II Magnetic Resonance (MR) Imaging System Common/Usual Name: Magnetic Resonance Imaging Accessories Proprietary Name: Kinematic Positioning Devices: C-Spine, Knee and Shoulder Establishment Registration Manufacturer: Picker Nordstar, Inc. P.O. Box 33 FIN-00511 Helsinki, FINLAND Phone: +358-9-394 127 Fax: +358-9-146 2811 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. ## 2. Intended Uses The Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder. PICKER INTERNATIONAL, INC. (KINE) 2/19/97 {1} 12:48 3. Device Description C-Spine Positioning Device The Outlook C-spine positioning device is designed to keep the head of the patient constrained in different positions while the C-spine is being imaged in the Outlook scanner. The device allows flexion, extension, lateral movement and lateral rotation. There is also a possibility to set the distance between the horizontal (flexion/extension) axis and the vertical axis (lateral motion). The device has an integrated holder for the Multipurpose receiver coil. Knee Positioning Device The Outlook Knee positioning device is designed to keep the leg constrained in different positions while the knee joint is imaged in the Outlook system with a Multipurpose coil. The device is used for flexion and extension of the knee. Shoulder Positioning Device The Outlook Knee positioning device is designed to keep the arm of the patient constrained in different positions while the shoulder joint is being imaged in the Outlook scanner. The device allows abduction, adduction and internal/external rotation. The device has an integrated holder for the Multipurpose receiver coil. 4. Safety and Effectiveness The Picker International Kinematic Positioning Devices for the Outlook are similar in technological characteristics and intended use to the Siemen's Kinematic Knee Device for the Magnetom Open System (K961121). The following chart has been created to demonstrate their substantial equivalence. PICKER INTERNATIONAL, INC. (KINE) 2/19/97 I-2 {2} 216-473-5721 11111111111111111111111111111111111 10 97 12:48 # SUBSTANTIAL EQUIVALENCE CHART | Parameter | Kinematic Positioning Devices for the Outlook | Predicate Device Kinematic Knee Device for the Magnetom Open System (K961121) | | --- | --- | --- | | Material | Same | No ferromagnetic materials which could affect the scan field. | | Device operation | Same | Manually operated by the user. No active components such as motors. | | Indications for Use | C-Spine, Knee, Shoulder scanning | Knee scanning | | Intended use | The Siemens Magnetom Open is a magnetic resonance imaging system which uses time-varying magnetic field gradients and rf energy to spatially encode the anatomy of the patient. The kinematic knee device will enable the physician to evaluate the anatomy of the knee and dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). The Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). | | PICKER INTERNATIONAL, INC. (KINE) 2/19/97 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K964752](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K964752) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com