Who is the manufacturer of ASSET APOLLO?

Philips Medical Systems (Cleveland), Inc. filed the 510(k) submission for ASSET APOLLO (K971884).

What is the FDA product code for ASSET APOLLO?

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

What is the regulatory pathway for ASSET APOLLO?

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

What are the predicate devices for ASSET APOLLO?

ASSET (K933835); EDGE/VISTA with System Enhancement Package (K964626).

Who can help prepare an FDA 510(k) submission like ASSET APOLLO?

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.

ASSET APOLLO

K971884 · Philips Medical Systems (Cleveland), Inc. · LNH · Aug 20, 1997 · Radiology

Device Facts

Record ID	K971884
Device Name	ASSET APOLLO
Applicant	Philips Medical Systems (Cleveland), Inc.
Product Code	LNH · Radiology
Decision Date	Aug 20, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The Picker International ASSET 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 the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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.

Device Story

ASSET APOLLO is an enhancement to the Picker International ASSET MRI system. It utilizes a water-cooled, self-shielded gradient system with increased performance (16 mT/m strength, 25 mT/m/msec slew rate) and a 5.0 kW RF amplifier. The system acquires NMR signals from protons in the head and whole body, transforming them into images based on proton density, flow velocity, T1, and T2 relaxation times. Operated by trained clinicians in a clinical setting, the system provides images for physician interpretation to aid in diagnosis. It features the 'AcuScan' package and supports standard imaging sequences (2DFT, 3DFT, Field Echo, Spin Echo, Inversion Recovery, FAST) plus advanced techniques like Angiography, Cardiac Imaging, Variable Fast Spin Echo, GRaSE, and Echo Planar Imaging. The system includes a computer subsystem for simultaneous scanning and image reconstruction, with DICOM v3.0 compliance for network communication. Benefits include improved gradient performance and scan/reconstruction rates compared to the predicate ASSET system.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of system specifications, including gradient performance, RF subsystem capabilities, and acoustic noise measurements.

Technological Characteristics

Water-cooled self-shielded gradient system; 16 mT/m max gradient strength; 25 mT/m/msec max slew rate; 5.0 kW single frequency RF amplifier; Phosphorous-bronze RF screen; UNIX/X-Windows based operating software; DICOM v3.0 compliant Ethernet connectivity; supports 2DFT/3DFT imaging sequences; includes AcuScan package.

Indications for Use

Indicated for use as an NMR device to produce images of the head and whole body based on proton density, flow velocity, T1, and T2 parameters to assist trained physicians in diagnosis. No specific age or gender restrictions; contraindicated for patients where MRI is generally contraindicated.

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

ASSET (K933835)
EDGE/VISTA with System Enhancement Package (K964626)

Related Devices

K964626 — EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE · Philips Medical Systems (Cleveland), Inc. · Feb 10, 1997
K954646 — EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS · Philips Medical Systems (Cleveland), Inc. · Jan 18, 1996
K142361 — Discovery MR750 3.0T · Ge Medical Systems, LLC · Dec 5, 2014
K173382 — Vantage Galan 3T, V4.6 · Toshibamedical Systems Corporation · Jan 26, 2018
K212056 — Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR · Canon Medical Systems Corporation · Aug 4, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ # K971884 AUG 2 0 ## SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) | 1. | General Information Classification: | Class II - Magnetic Resonance Imaging System | |----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Common/Usual Name: | Magnetic Resonance Imaging System | | | Proprietary Name: | ASSET APOLLO | | | Establishment Registration: | Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 FDA Owner Number: #1580240 FDA Registration Number: #1525965 | | | Performance Standards: | No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act. | #### 2. Intended Uses The ASSET APOLLO does not change the existing intended use for the ASSET system as defined below. The Picker International ASSET 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 the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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. #### 3. Device Description The ASSET APOLLO MR system includes the following enhancements: a water cooled gradient system, increased gradient performance, increased scan/reconstruction rates, and a user selectable bandwidth option. #### 4. Safety and Effectiveness The ASSET APOLLO is similar in technological characteristics and intended use to the standard ASSET system and the EDGE/VISTA system enhancement package. The following chart has been created to demonstrate their substantial equivalence. | PICKER INTERNATIONAL, INC. | (APOLLO) | 5/8/97 | I - 1 | |----------------------------|----------|--------|-------| |----------------------------|----------|--------|-------| . {1}------------------------------------------------ ## SUBSTANTIAL EQUIVALENCE CHART ﺴﻌﻪ ﺍ | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | |----------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Computer Subsystem | Same as K964626. | Display/Database computer and scan reconstruction hardware connected together by a dedicated Ethernet communications system. Allows for simultaneous scanning and image reconstruction/manipulation. Single monitor for system operation and image review. Second Ethernet interface allows for communication with systems on the external network. | Display/database computer, monitor and Ethernet communications systems. Ethernet communications link complies with DICOM v3.0 to allow image transfer to other MR, CT, Nuclear, workstation systems and cameras. Optional packages available for increased image reconstruction rates. | | Image Storage Short Term: Archival: | Same. Same. | Magnetic Disk Optical Disk | Magnetic Disk Optical Disk | | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | | Gradient Subsystem Gradient Coils: | Water-cooled self-shielded gradient system. Phosphorous- bronze RF screen. | Self-shield gradient coil designed for Magnex 0.5T actively shielded magnet. Copper RF screen. | Water-cooled self-shielded gradient system for all performance levels. Stainless steel RF screen. | | Max. Gradient Strength | 16 mT/m | 10 mT/m | 16, 20 or 27 mT/m | | Max. Slew Rate | 25 mT/m/msec | 18 mT/m/msec | 25, 40, 72 mT/m/msec | | Gradient Amps: | 150 A RMS, 300 A peak, 400 V | Single high current drive amplifier per axis. | 150 A RMS, 300 A peak, 400 V or 270 A RMS, 440 A peak, 600 V | | RF Subsystem | | | | | DTR Spectrometer: | Same. | Single channel with fast sampling ADC and additional digital filtering. Three additional receive channels are available as an option. | Single Channel with fast sampling ADC and additional digital filtering. Three additional receive channels are available as an option. | | RF Amplifiers: | Single frequency 5.0 kW RF amplifier. | Single frequency 2.5 kW RF amplifier. | Single frequency RF amplifiers. | | Body Coil | Same as K933835. | 57 cm quadrature multi- conductor transmit/receive. | 61 cm quadrature multi-conductor transmit/receive coil. | | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | | Head Coil | Same. | Quadrature multi-conductor receive only. | Quadrature multi-conductor receive only. | | Receive Only Coil Connection | Same. | All receive only coils plug into single couch RF connector. | All receive only coils plug into single couch RF connector. | | Transmit/Receive Box | Same. | Four receive channels in system. (1 standard, 4 optional) | Four receive channels in system. (1 standard, 4 optional) | | Magnet Subsystem | Same as K933835. | Actively shielded magnet offered at 0.5 T. | Active Shield Magnets offered at 1.5 T and 1.0 T. | | Patient Handling | Same as K933835. | Horizontal motion only, computer controlled patient transport system. | Computer controlled patient transport system with vertical and horizontal motion. | | Magnet Facade | Same. | Cylindrical fiberglass enclosure. | Cylindrical fiberglass enclosure. | | Power Distribution Subsystem | Same. | Isolation transformer, transient suppression circuitry, and power distribution center all contained in a single cabinet. | Isolation transformer, transient suppression circuitry, and power distribution center all contained in a single cabinet. | | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | | Operating Software | Same as K964626. | UNIX - X Windows based operating software. Graphical User Interface - windows and Multi-tasking capability provided. | UNIX - X Windows based operating software. Graphical User Interface - windows and multi-tasking capability provided | | | | SCAN, VIEW, FILM, and UTILITIES operations all accessed from single console. | SCAN, VIEW, FILM and UTILITIES operations all accessed from single console. | | | | Able to switch between on-going tasks. | Able to switch between on-going tasks. | | Operational Features | Same. | SCAN capabilities include: Pilot positioning on three different reference images. Preloaded anatomical protocol categories. | SCAN capabilities include: Pilot positioning on three different reference images. Preloaded anatomical protocol categories. | | | | VIEW capabilities include: Multiplanar reconstruction and curvilinear reformatting. | VIEW capabilities include: Multi planar reconstruction and curvilinear reformatting. | | | | FILM capabilities include: ability to set film formats and load print queue directly from Display/Database computer. | FILM capabilities include: ability to set film formats and load print queue directly from Display/Database computer. | | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | | Standard Imaging Sequences | Same standard imaging sequences with the addition of the AcuScan package. | 2DFT: Field Echo, Spin Echo, Multiple Echo, Inversion Recovery and FAST. 3DFT: FAST | 2DFT: Field Echo, Spin Echo, Multiple Echo, Inversion Recovery and FAST. 3DFT: FAST | | Acquisition and Reconstruction Techniques | Same as K964626. | Main features include: Presaturation, phase conjugate symmetry, TrueRes, TrueSlice, and Geometric Distortion Correction. | Main features include: Presaturation, phase conjugate symmetry, TrueRes and TrueSlice. | PICKER INTERNATIONAL, INC. I. 5/8/97 I - 2 'معرب ا {2}------------------------------------------------ ﻣﺴﺴﺴﺴﺔ PICKER INTERNATIONAL, INC. .. (APOLLO) 5/8/97 I - 3 نسببها {3}------------------------------------------------ ' · مسلا PICKER INTERNATIONAL, INC. ) 5/8/97 ﻟﺴﻴﺮ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- {4}------------------------------------------------ ﺳﺴﻪ PICKER INTERNATIONAL, INC. امارات سنڌ ا 5/21/97 I - 5 ب {5}------------------------------------------------ ﻤﺴﻴﺴﻪ ﺍ PICKER INTERNATIONAL, INC. - I - 6 {6}------------------------------------------------ | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | |------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Optional Receive Only Coils and Accessories | Same as K933835. | Large Joint Coil Small Joint Coil Volume Neck Coil Quad Spine Coil and Positioner Bilateral TMJ Coil (Linear and Phased Array versions) Bilateral Breast Coil General Purpose Flex Coil C/T/L Phased Array Pelvic Phased Array Flexible Body Coil - Quadrature Quadrature Wrist Coil Quadrature Lower Extremity Coil Coil Combiner | Large Joint Coil Small Joint Coil Volume Neck Coil Quad Spine Coil and Positioner Bilateral TMJ Coil (Linear and Phased Array versions) Bilateral Breast Coil General Purpose Flex Coil C/T/L Phased Array Pelvic Phased Array Flexible Body Coil (Quadrature and Phased Array versions) Quadrature Wrist Coil Quadrature Lower Extremity Co Coil Combiner Head-Neck Vascular Phased A Shoulder Phased Array | | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | | Software Options | Angiography | Angiography | Angiography | | | Cardiac Imaging | Cardiac Imaging | Cardiac Imaging | | | Variable Fast Spin Echo Sequences (2, 4, 8, 16, 32, 48 and 64 echo sequences) | Variable Fast Spin Echo Sequences. | Variable Fast Spin Echo (2, 4, 8, 16, 32, 48 and 64 echo sequences) | | | Gradient-Recalled and Spin-Echo (GRaSE) Technique | Gradient-Recalled and Spin-Echo (GRaSE) Technique | Gradient-Recalled and Spin-Echo (GRaSE) Technique | | | Echo Planar Imaging | Echo Planar Imaging | Echo Planar Imaging | | Time Varying Magnetic Field | Same as K964626. | Not to exceed 20 T/s. | Normal Operating Mode: dB/dt ≤ 40 T/s | | | | | First Controlled Operating Mode: 40 T/s < dB/dt ≤ 60 T/s | | Radiofrequency Absorption | Same as K964626. | Normal Operating Mode: Limited to a maximum level of 1.2 W/kg. | Normal Operating Mode: Limited to a maximum level of 1.2 W/kg. | | | | First Level Controlled Operating Mode: Limited to a maximum value of 2.4 W/kg. | First Level Controlled Operating Mode: Limited to a maximum value of 3.2 W/kg. | | ITEM | ASSET APOLLO | Predicate Device ASSET (K933835) | Predicate Device EDGE/VISTA with System Enhancement Package (K964626) | | Acoustic Noise | | | | | Typical | 71.7 dBA (average) 82.9 dB (peak) | 83.8 dBA (average) 96.8 dB (peak) | 80.6 dBA (average) 93.3 dB (peak) | | Worst Case | 88.8 dBA (average) 96.3 dB (peak) | 98.2 dBA (average) 108.2 dB (peak) | 115.1 dBA (average) 123.8 dB (peak) | | Intended Use | Same. | The Picker International ASSET 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 the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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 Picker International EDGE / VISTA systems are intended for use as a NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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. | ﻤﺴﺴﺴﺴ PICKER INTERNATIONAL, INC. ﺮ ﺍﻟﺴﻨﺔ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴ (APOLLO) 5/8/97 I - 7 {7}------------------------------------------------ مسس PICKER INTERNATIONAL, INC. ﺳﺴﺴﺔ ﻧ 5/8/97 I - 8 سسيدا {8}------------------------------------------------ PICKER INTERNATIONAL, INC. 5/8/97 (APOLLO) I.- I - 9 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 5500 Avion Park Drive Highland Heights, Ohio 44143 Re: K971884 ASSET APOLLO (MRI System) Dated: May 12, 1997 Received: May 22, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH AUG 20 1997 Dear Dr. Keeler: We have reviewed your Section SI0(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. 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 and additionally 809.10 for in צוות diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/edri/dsmamain.html" Sincerely yours. William Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ 510(k) Number (if known): __Ka7 1884 Device Name: ASSET APOLLO ### - Indications for Use: The ASSET APOLLO does not change the existing intended use and indications for the ASSET system as defined below. The Picker International ASSET 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 the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David L. Shapiro (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) ✓ OR Over-The-Counter Use _ (Optional Format 1-2-96)

ASSET APOLLO

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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ASSET APOLLO

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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