Who is the manufacturer of PANORAMA ENHANCEMENTS?

Philips Medical Systems, Inc. filed the 510(k) submission for PANORAMA ENHANCEMENTS (K024042).

What is the FDA product code for PANORAMA ENHANCEMENTS?

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

What is the regulatory pathway for PANORAMA ENHANCEMENTS?

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

What are the predicate devices for PANORAMA ENHANCEMENTS?

Philips Panorama 0.6T System (K013858); Philips Intera family (0.5T, 1.0T, 1.5T) (K001796); Philips Panorama 0.23 T System (K974844).

Who can help prepare an FDA 510(k) submission like PANORAMA ENHANCEMENTS?

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.

PANORAMA ENHANCEMENTS

K024042 · Philips Medical Systems, Inc. · LNH · Feb 4, 2003 · Radiology

Device Facts

Record ID	K024042
Device Name	PANORAMA ENHANCEMENTS
Applicant	Philips Medical Systems, Inc.
Product Code	LNH · Radiology
Decision Date	Feb 4, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The Panorama System is indicated 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 training physician, these images yield information that can be useful in the determination of a diagnosis.

Device Story

Panorama Enhancements are updates to existing Panorama 0.6T and 0.23T MRI systems. Device utilizes nuclear magnetic resonance (NMR) to generate images based on proton density, flow velocity, T1, and T2 relaxation times. Input signals are processed to produce soft tissue images of head and whole body. Operated by trained clinicians in clinical settings. Enhancements include modified operating limits for dB/dt and software improvements. Output is interpreted by physicians to assist in clinical diagnosis. Benefits include diagnostic imaging capabilities consistent with predicate systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technical specifications, operating parameters, and software functionality against predicate devices.

Technological Characteristics

Magnetic resonance imaging system. Materials: ABS plastic (magnet facade), fiberglass. Sensing: Water-cooled self-shielded gradient coils. Energy: RF transmitter coils, RF amplifiers (up to 9 kW). Connectivity: Windows 2000-based GUI, DICOM-compatible. Software: Multi-tasking scan/reconstruction software. Operating modes comply with IEC 60601-2-33 (second edition).

Indications for Use

Indicated for patients requiring MRI imaging of the head and whole body to visualize soft tissue structure for diagnostic purposes. No specific age or gender contraindications stated.

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

Philips Panorama 0.6T System (K013858)
Philips Intera family (0.5T, 1.0T, 1.5T) (K001796)
Philips Panorama 0.23 T System (K974844)

Reference Devices

Breast (K002539, MRI Devices Corp.)
Large Neck (K981959, Picker International, Inc.)
TMJ (013528, USA Instruments, Inc.)
Shoulder (K983143, USA Instruments, Inc.)

Related Devices

K013858 — INFINION 0.6T MR IMAGING SYSTEM · Philips Medical Systems (Cleveland), Inc. · Jan 22, 2002
K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR · Canon Medical Systems Corporation · Mar 27, 2026
K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910) · Esaote, S.p.A. · Jun 26, 2024
K983110 — FLEXART,FLEXART/HYPER, VISART, VISART/HYPER · Toshiba America Mri, Inc. · Feb 25, 1999
K113511 — ECHOSTAR SPICA 1.5T MR SYSTEM · Alltech Medical Systems America, Inc. · May 2, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Kò2 4042 ### SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) #### 1. General Information | Classification: | Class II Magnetic Resonance Imaging (MRI) System | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Magnetic Resonance Imaging (MRI) System | | Proprietary Name: | Panorama Enhancements | | Establishment Registration: | Manufacturing Location: Philips Medical Systems MR Technologies Finland Oy P.O. Box 185 Vantaa, Finland FIN-00511 Phone: 358925359300 FDA Facility Registration: #9680194 FDA Owner #1580240 Contact: Attn: Duane C. Praschan Philips Medical Systems (Cleveland) 595 Miner Road Highland Heights, OH 44143 Phone: 440-483-5743 | | Performance Standards: | No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act | #### 2. Intended Uses The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems as defined below: The Panorama System is indicated 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 training physician, these images yield information that can be useful in the determination of a diagnosis. ### 3. Device Description | Philips Medical Systems | Panorama Enhancements | 11/22/02 | Att I | |----------------------------|-----------------------|------------|-------| | MR Technologies Finland Oy | | page 1 / 6 | | {1}------------------------------------------------ Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements. ## Safety and Effectiveness The functionality included in the Panorama Enhancements are similar in technology characteristics and intended use to the Panorama 0.6T and 0.23T MR Imaging Systems and Philips' Intera family. | Parameter | Panorama 0.6T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | Panorama 0.23 T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Panorama 0.23 T System K974844 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | |-------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Gradient Subsystem | | | | | | Gradient Coils: | Same. | Water-cooled self- shielded gradient system. K013858 | Same. | Water-cooled self-shielded gradient system. K974844 | | Max. Gradient Strength: | 23 mT/m. | 20 mT/m K013858 | 21 mT/m | 16 mT/m (x,y direction), 18 mT/m (z direction) K974844 | | Max. Slew Rate: | 75 T/m/s. | 40 T/m/s K013858 | 50 T/m/s | 25 T/m/s (x,y direction), 40 T/m/s (z direction) K974844 | | RF Subsystem | | | | | | RF amplifiers: | Same. | Max power 9 kW K013858 | Same. | 5 kW solid state K013858 | | RF transmitter coils: | Same. | Upper and lower, planar coils, integrated in the magnet, water cooling. Tuning adjusted to 0.6T field strength. K013858 | Same. | Upper and lower, planar coils, integrated in the magnet. Tuning adjusted to 0.23T field strength. K013858 | | Receive only RF coils: | Same and Synergy Head and Neck | Head, Head and Neck, Neck, Extremity, Body and Spine, Multipurpose (different sizes), TMJ, Breast, Shoulder. K013858 | Same and Synergy Body. | Head, Brain, Head and Neck, Neck, Extremity, Body and Spine (different sizes), Flexible spine, Flexible Multi- Purpose (different sizes), Small Extremity (K974844) Breast (K002539, MRI Devices Corp.) Large Neck (K981959 Picker International, Inc.) TMJ (013528, USA Instruments, Inc.) Shoulder (K983143,USA Instruments, Inc.) | | Magnet Enclosure | | | | | | Parameter | Panorama 0.6T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | Panorama 0.23 T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Panorama 0.23 T System K974844 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | | Magnet Façade: | New design, cover backdoor of ABS, otherwise material the same. | Fiberglass enclosure. K013858 | New design, cover backdoor of ABS, otherwise material the same. | Fiberglass enclosure. K974844 | | Operating Software | | | | | | Base Software: | Same. | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi- tasking capability. K013858 | Same. | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi-tasking capability. K013858 | | MRGP software: | Same. | Interventional MRI capabilities. K013858 | Same. | Interventional MRI capabilities. K013858 | | Imaging sequences | | | | | | Main features include: | Same. | Field Echo, Spin Echo, Dual Echo, Dual Spin Echo, Inversion Recovery, Dual Inversion Recovery, Fast Spin Echo, EXPRESS, CBASS, MRCP, MRA, STIR, FLAIR, TSHIRT, RF- FAST, CE-FAST, DWISE. K013858 | Same. | Field Echo, Spin Echo, Dual Echo, Dual Spin Echo, Inversion Recovery, Dual Inversion Recovery, Fast Spin Echo, EXPRESS, CBASS, MRCP, MRA, STIR, FLAIR, TSHIRT, RF-FAST, CE- FAST, DWISE. K013858 | | Acquisition and reconstruction techniques | | | | | | Parameter | Panorama 0.6T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | Panorama 0.23 T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Panorama 0.23 T System K974844 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | | Main features include: | Same. | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice. MAO, MAST, presaturation, chemical fat saturation, phase conjugate symmetry, read conjugate symmetry, true res, true slice, elliptic encoding, RAM, CODA, MTC, dynamic examination curve, contrast dynamic imaging, reconstruction filters, respiratory gating, multiplanar reconstruction, maximum intensity projection, phase correction, fat/water suppression, ADC map. K013858 SENSE capability. K001796 SyncraScan | Same. | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice. MAO, MAST, presaturation, chemical fat saturation, phase conjugate symmetry, read conjugate symmetry, true res, true slice, elliptic encoding, RAM, CODA, MTC, dynamic examination curve, contrast dynamic imaging, reconstruction filters, respiratory gating, multiplanar reconstruction, maximum intensity projection, phase correction, fat/water suppression, ADC map. K013858 SENSE capability. K001796 SyncraScan | | User Interface | Layout change, see Figure 2b. | Layout, see Figure 2a. | Layout change, see Figure 2b. | Layout, see Figure 2a. | | Time Varying | | | | | | Parameter | Panorama 0.6T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | Panorama 0.23 T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Panorama 0.23 T System K974844 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | | Normal Operating Mode: | ≤ 35.4 T/s (IEC60601- 2-33, second edition, directly determined) | According to IEC 60601-2-33 FDIS script 2001-11-02, default. K013858 | ≤ 35.4 T/s (IEC60601-2- 33, second edition, directly determined) | ≤ 40 T/s K974844 | | First Level Controlled Operating Mode: | ≤ 44.3 T/s (IEC60601- 2-33, second edition, directly determined) | According to IEC 60601-2-33 FDIS script 2001-11-02, default. K013858 | ≤ 44.3 T/s (IEC60601-2- 33, second edition, directly determined) | ≤ 60 T/s K974844 | | Radiofrequency Absorption | | | | | | Normal Operating Mode: | Same. | Limited to a maximum level of 1.2 W/kg. K013858 | Same. | Limited to a maximum level of 1.2 W/kg. K974844 | | First Level Controlled Operating Mode: | Same. | Limited to a maximum value of 3.2 W/kg. K013858 | Same. | Limited to a maximum value of 3.2 W/kg. K974844 | | Acoustic Noise | | | | | | Typical: | Same. | 87 dBA (average) 102 dBA (peak) K013858 | Same. | A-weighted average value < 85 dBA K974844 | | Worst Case: | Same. | 91 dBA (average), 104 dB (peak) K013858 | Same. | A-weighted average value < 85 dBA, 98 dB peak K974844 | # Substantial Equivalence Chart Philips Medical Systems MR Technologies Finland Oy Panorama Enhancements 11/22/02 Att I page 2 / 6 {2}------------------------------------------------ - {3}------------------------------------------------ {4}------------------------------------------------ {5}------------------------------------------------ | Parameter | Panorama 0.6T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | Panorama 0.23 T MR Imaging System | Predicate Device - Philips Panorama 0.6T System K013858 - Philips Panorama 0.23 T System K974844 - Philips Intera family (0.5T, 1.0T, 1.5T) K001796 | |-----------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use and Indications for Use | Same, note the system name change. | The Proview System is indicated 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. K013858 | Same, note the system name change. | The Proview System is indicated 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. K013858 | : . {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a triple-lined design resembling an abstract bird or wing-like shape, oriented diagonally within the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 0 4 2003 Mr. Duane C. Preschan Manager, MR Regulatory Affairs Philips, Medical Systems, Inc. 595 Miner Road HIGHLAND HEIGHTS OH 44143 Re: K024042 Trade/Device Name: Panorama Enhancements Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 22, 2002 Received: December 6, 2002 Dear Mr. Preschan: 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 (PMA), it may be subject to 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. {7}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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 {8}------------------------------------------------ 510(k) Number (if known): Device Name: Panorama Enhancements Indications for Use: Intended Use The Panorama Enhancements do not change the existing indications as defined below. The Panorama MR Imaging System is indicated 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) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K024042 | |---------------|---------| |---------------|---------| Prescription Use V (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)

PANORAMA ENHANCEMENTS

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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PANORAMA ENHANCEMENTS

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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