MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:

Q: Who is the manufacturer of MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:?

Medical Advances, Inc. filed the 510(k) submission for MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: (K964813).

Q: What is the FDA product code for MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K964813 · Medical Advances, Inc. · MOS · Feb 26, 1997 · Radiology

Device Facts

Record ID	K964813
Device Name	MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
Applicant	Medical Advances, Inc.
Product Code	MOS · Radiology
Decision Date	Feb 26, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

Diagnostic Uses: 2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging. Anatomic Regions: Vascular structures, soft tissue and musculoskeletal structures in the lower extremities (mid-abdomen to mid-foot)

Device Story

The Model 675GE-64 Peripheral Vascular Coil is a phased array MRI coil system consisting of a Lower Extremity Flexible Array (Model 665GE-64) and a Medium General Purpose Flex Coil (Model 538GE-64). Designed for use with GE Signa 1.5T MRI systems, the device captures radiofrequency signals from the patient's lower extremities. These signals are processed by the host MRI system to generate diagnostic images. Operated by radiologists or MRI technicians in clinical settings, the coil facilitates high-resolution imaging of vascular and musculoskeletal anatomy. The device does not alter the MRI system's safety parameters (static magnetic field, RF power, acoustic noise) or imaging performance metrics (SNR, uniformity, distortion). It provides clinicians with detailed anatomical visualization to support diagnostic decision-making.

Clinical Evidence

Bench testing only. The submission relies on performance comparisons demonstrating that the device does not alter the safety or imaging performance specifications of the GE Signa 1.5T MRI system.

Technological Characteristics

Phased array MRI coil system; compatible with GE Signa 1.5T MRI systems. Materials comply with UL 94 (flammability) and CPAI-84 (flame resistance). Electrical safety complies with UL 544 and IEC 601-1. Passive sensing device; no internal software or active processing algorithms.

Indications for Use

Indicated for diagnostic imaging of vascular structures, soft tissue, and musculoskeletal structures in the lower extremities (mid-abdomen to mid-foot) using 2D/3D imaging, proton density, T1/T2 weighted imaging, and time-of-flight/phase contrast imaging on GE Signa 1.5T MRI systems.

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.

Related Devices

K023848 — MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: · Igc-Medical Advances, Inc. · Feb 14, 2003
K022395 — 1.5T SCANMED PV ARRAY · Medic, Inc. · Aug 13, 2002
K040640 — MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL · Igc-Medical Advances, Inc. · Mar 22, 2004
K983109 — MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY · Medical Advances, Inc. · Oct 6, 1998
K982339 — FLOW 7000 PERIPHERAL VASCULAR COIL · Usa Instruments, Inc. · Sep 4, 1998

Submission Summary (Full Text)

{0} FEB 26 1997 # 510(k) Summary of Safety and Effectiveness K964813 | Device Name | Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil | | --- | --- | | Applicability | Compatible with GE Signa 1.5T MRI systems with Phased Array option | | Reason for 510(k) | New device | | Classification Name | Magnetic Resonance Diagnostic Device | | Device Classification Panel | Radiology | | Device Classification Number | 892.1000 | | Product Code | 90LNH | | Common Name | Magnetic Resonance Imaging Coil | | Proprietary Name | Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil | | Establishment Registration Number | 2183683 | | Address of MFG Facility | Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226 | | Point of Contact | Thomas E. Tynes Vice President - Operations (414) 258-3808 Ext. 407 | | Classification | Class II | | Intended Uses | | | Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging. | | Anatomic Regions | Vascular structures, soft tissue and musculoskeletal structures in the lower extremities (mid-abdomen to mid-foot) | {1} Standards | Performance Standards | None Established under Section 514 | | | --- | --- | --- | | Voluntary Safety Standards | UL 544 | Medical and Dental Equipment | | | UL 94 | Tests for Flammability of Plastic Materials | | | IEC 601-1 | General Safety Requirements for Medical Electrical Equipment | | | CPAI-84 | Specification for Flame Resistant Material Used in Camping Tentage | ## Overview The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns: The GE 1.5T Signa MRI system operated with the Medical Advances Peripheral Vascular Coil is substantially equivalent to the same system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels: ## Safety Parameters Maximum Static Magnetic Field: No change Rate of Magnetic Field Strength Change: No change RF Power Deposition: No change Acoustic Noise Levels: No change {2} ## Imaging Performance Parameters | Specification Volume: | No change | | --- | --- | | Signal-to-Noise Ratio: | No change | | Image Uniformity: | No change | | Geometric Distortion: | No change | | Slice Thickness and Gap: | No change | | High Contrast Spatial Resolution: | No change | ## General Safety and Effectiveness Concerns The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device. ## Substantial Equivalence Summary The GE 1.5T Signa MRI system operated with the Medical Advances Peripheral Vascular Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa system safety parameter specifications.