Who is the manufacturer of InVision 1.5 Surgical Theatre?

Deerfield Imaging, Inc. filed the 510(k) submission for InVision 1.5 Surgical Theatre (K240157).

What is the FDA product code for InVision 1.5 Surgical Theatre?

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

What is the regulatory pathway for InVision 1.5 Surgical Theatre?

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

Who can help prepare an FDA 510(k) submission like InVision 1.5 Surgical Theatre?

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.

InVision 1.5 Surgical Theatre

K240157 · Deerfield Imaging, Inc. · LNH · Feb 15, 2024 · Radiology

Device Facts

Record ID	K240157
Device Name	InVision 1.5 Surgical Theatre
Applicant	Deerfield Imaging, Inc.
Product Code	LNH · Radiology
Decision Date	Feb 15, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

The InVision 1.5 Surgical Theatre is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite.

Device Story

InVision 1.5 Surgical Theatre is a ceiling-mounted, rail-based MRI system integrating a Siemens MAGNETOM Sola 1.5T scanner. Device enables intraoperative imaging by moving the magnet between a diagnostic room (DR) and an operating room (OR) on overhead rails while the patient remains stationary on an OR table. System includes magnet mover, turret assembly, cable management, and collision detection (IPACS). Operated by clinical staff in hospital settings. Provides MR images to surgeons for real-time guidance during procedures without altering clinical workflow. Benefits include reduced patient transport risks and improved surgical precision through intraoperative visualization.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by bench testing, including system functional testing, imaging performance verification, software verification, acoustic energy analysis, and heating verification. Sample clinical images were assessed to confirm diagnostic quality.

Technological Characteristics

1.5T superconducting, actively shielded MRI scanner. Ceiling-mounted rail system with friction-based, belt-driven rollers. Components: stainless steel rails, acetal rollers, flexible cable carriers, IPACS collision detection. Biocompatible materials per ISO 10993; sterilization per ISO 11135. Connectivity: standard Siemens RF coils and interface cables. Software: magnet mover control software.

Indications for Use

Indicated for patients requiring MR imaging of head, body, or extremities for diagnostic purposes. Used for intraoperative and interventional procedures when paired with MR-safe/conditional devices. No specific age or gender restrictions.

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

IMRIS iMRI 3T V (K212367)

Reference Devices

Siemens MAGNETOM Sola (K203443)
Siemens MAGNETOM Vida (K192924)
HC300 Coil (K103506)
InSitu Coil 3T (K123091)

Related Devices

K252239 — InVision 3T Recharge Operating Suite · Imris Imaging, Inc. · Aug 6, 2025
K212367 — IMRIS iMRI 3T V · Deerfield Imaging, Inc. · Aug 23, 2021
K133692 — IMRI 1.5T AND IMRI 3T S · Imris, Inc. · Feb 10, 2014
K061916 — NEURO II-SE, MODELS OR-MB-DR AND OR-DR · Imris, Inc. · Aug 11, 2006
K050132 — NEURO II-S · Innovative Magnetic Resonance Imaging Systems, Inc. · Feb 15, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Feburary 15, 2024 Deerfield Imaging, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114 Re: K240157 Trade/Device Name: InVision™ 1.5 Surgical Theatre Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: January 19, 2024 Received: January 19, 2024 Dear Prithul Bom: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K240157 Device Name InVision™ 1.5 Surgical Theatre #### Indications for Use (Describe) The InVision 1.5 Surgical Theatre is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary ### I. SUBMITTER | Establishment: | Deerfield Imaging, Inc. 1230 Chaska Creek Way, Suite 100 Chaska, MN 55318 USA | |-----------------|-------------------------------------------------------------------------------------| | Date Prepared: | December 21, 2023 | | Contact Person: | Liz Ashworth | | Phone: | 218-256-7150 | #### II. DEVICE | Device Name: | InVision™ 1.5 Surgical Theatre | |----------------------|--------------------------------------------------------------| | Common Name: | MRDD (Magnetic Resonance Diagnostic Device) | | Classification Name: | System, Nuclear Magnetic Resonance Imaging (21 CFR 892.1000) | | Regulatory Class: | II | | Product Code: | Primary: LNH Secondary: LNI, MOS | #### III. PREDICATE DEVICE | Device Name: | IMRIS iMRI 3T V | |----------------------|--------------------------------------------------------------| | 510(k) Number: | K212367 | | Common Name: | MRDD (Magnetic Resonance Diagnostic Device) | | Classification Name: | System, Nuclear Magnetic Resonance Imaging (21 CFR 892.1000) | | Regulatory Class | II | | Product Code: | Primary: LNH Secondary: LNI, MOS | The reference device used in the submission is the K203443 Siemens MAGNETOM Sola. #### IV. DEVICE DESCRIPTION The proposed InVision™ 1.5 Surgical Theatre is a traditional Magnetic Resonance Imaging (MRI) scanner that is suspended on an overhead rail system. It is designed to operate inside a Radio Frequency (RF) shielded room to facilitate intraoperative and multi-room use. The InVision 1.5 Surgical Theatre uses a scanner, the Siemens MAGNETOM Sola (K203443, reference device), to produce images of the internal structures of the head as well as the whole body. The Siemens 1.5T MAGNETOM Sola MRI scanner is an actively shielded magnet with a magnetic field strength of 1.5 Tesla. The InVision 1.5 Surgical Theatre provides surgeons with access to magnetic resonance (MR) images while in the surgical field without changing the surgical/clinical workflow. When images are requested in the operating room (OR), the magnet is moved from the diagnostic room (DR) to the OR on a pair of overhead rails while the patient remains stationary during the procedure. {4}------------------------------------------------ ## SIMPIS Imaging is performed and once complete the magnet is moved out of the OR to the DR. The magnet can be moved in and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. When the Siemens MAGNETOM Sola MRI scanner is in the DR, the OR may be used as a standard OR, utilizing standard surgical instruments and equipment during surgery. When not required in the OR, the scanner is available for use in the DR as a standard diagnostic MRI. ### V. INDICATIONS FOR USE The InVision 1.5 Surgical Theatre is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The proposed InVision 1.5 Surgical Theatre is shown to be substantially equivalent to the predicate device IMRIS iMRI 3T V (K212367) by comparing the indications for use, principles of operation, technological characteristics, and performance testing similarities and differences. The imaging functionality and software in the Siemens MAGNETOM Sola MRI is not modified from the standard floor-based Siemens MAGNETOM Sola (K203443. reference device). The accessories used in the InVision 1.5 Surgical Theatre, including the Intraoperative Imaging Coils, VISIUSmatrix, ORT400 Operating Room Table, Head Fixation Device (HFD100), Horseshoe Headrest, and IMRISeye, are substantially equivalent to the predicate IMRIS iMRI 3T V accessories. The technological characteristic difference between the proposed InVision 1.5 Surgical Theatre and the IMRIS iMRI 3T V predicate device is that the predicate device includes the Siemens MAGNETOM Vida scanner while the proposed device uses the Siemens MAGNETOM Sola scanner. Due to the difference in Siemens MRI scanner, the proposed device incorporates changes to magnet mover components and updates to the modifications made to the Siemens scanner when it is integrated with the InVision 1.5 Surgical Theatre (see Table 1). The technological characteristic difference rationale demonstrates that the proposed device is safe and effective as a legally marketed predicate device and does not raise different questions of safety and effectiveness. {5}------------------------------------------------ | Characteristic | Predicate Device iMRI 3T V K212367 | Proposed Device InVision 1.5 Surgical Theatre | Equivalence Comparison | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Regulation Number | 21 CFR 892.1000 | 21 CFR 892.1000 | Same | | Regulation Name | Magnetic resonance diagnostic device | Magnetic resonance diagnostic device | Same | | Product Code | Primary: LNH Secondary: LNI, MOS | Primary: LNH Secondary: LNI, MOS | Same | | Classification | Class II | Class II | Same | | Panel | Radiology | Radiology | Same | | Intended Use/Indications for Use | The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The IMRIS iMRI 3T V system may also be used for imaging during intra-operative | The InVision 1.5 Surgical Theatre is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The InVision 1.5 Surgical Theatre may also be used for imaging during intra-operative | Same | | Characteristic | Predicate Device iMRI 3T V K212367 | Proposed Device InVision 1.5 Surgical Theatre | Equivalence Comparison | | | and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. | and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. | | | | The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite. | The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite. | | | Siemens MAGNETOM MRI System | Siemens 3T MAGNETOM Vida (K192924) | Siemens 1.5T MAGNETOM Sola (K203443) | Different | | Static field strength of magnet | 3 Tesla | 1.5 Tesla | Different | | Type of magnet | Superconducting, Actively Shielded | Superconducting, Actively Shielded | Same | | Where used | Hospital operating room and diagnostic room | Hospital operating room and diagnostic room | Same | | IMRIS Surgical Theatre room configurations | • OR1-DR • DR-OR2 • OR1-DR90T • OR1-DR90 • DR90-OR2 • OR1-DR-OR2 • OR1-DR90-OR2 • OR1-DR90T-OR2 • OR1-DR CB • OR1-DR90 CB • OR1-DR90T CB • CB DR-OR2 • CB DR90-OR2 | • OR1-DR • DR-OR2 • OR1-DR90T • OR1-DR90 • DR90-OR2 • OR1-DR-OR2 • OR1-DR90-OR2 • OR1-DR90T-OR2 • OR1-DR CB • OR1-DR90 CB • OR1-DR90T CB • CB DR-OR2 • CB DR90-OR2 | Same | | Siemens diagnostic RF coils | Siemens standard RF coils | Siemens standard RF coils | Same | | IMRIS Intraoperative Imaging Coils | HC300 Coil (K103506) | HC150 Coil (K103506) | Similar | | Characteristic | Predicate Device iMRI 3T V K212367 | Proposed Device InVision 1.5 Surgical Theatre | Equivalence Comparison | | and coil interface cables | InSitu Coil 3T (K123091) 3T coil interface cables to connect and use Siemens RF coils in intraoperative settings | InSitu Coil 1.5T (K123091) 1.5T coil interface cables to connect and use Siemens RF coils in intraoperative settings | Similar | | Rail system (2 room and 3 room) | Stainless steel rails Rail covers Mounting clamp block assembly Rail accessories Striker bar End stops Limit switches | Stainless steel rails Rail covers Mounting clamp block assembly Rail accessories Striker bar End stops Limit switches | Same | | Magnet mover material | Steel and stainless steel | Steel and stainless steel | Same | | Mounting mechanism | Overhead rail beam and carriage with acetal rollers | Overhead rail beam and carriage with acetal rollers | Same | | Cable guards | Mechanical guards to protect cabling from magnet mover turret and hangers. | Mechanical guards to protect cabling from magnet mover turret. | Similar | | Hangers, stabilizers | Mechanical interfaces to connect the magnet mover structure. | Mechanical interfaces to connect the magnet mover structure. | Similar | | Turret assembly | Mechanical assembly that allows the magnet to rotate between 0° and 180°. | Mechanical assembly that allows the magnet to rotate between 0° and 180°. | Same | | Side carriages | Mechanical interface to connect the mover assembly to the ceiling mounted rails. | Mechanical interface to connect the mover assembly to the ceiling mounted rails. | Same | | Quench management | Flexible stainless steel quench line | Flexible stainless steel quench line | Same | | Quench manifold | Mechanical interface to connect the quench line. | Mechanical interface to connect the quench line. | Similar | | Cable management | Flexible cable carrier | Flexible cable carrier | Same | | Collision detection system | Integrated Pressure Activated Collision-detection System (IPACS) | Integrated Pressure Activated Collision-detection System (IPACS) | Similar | | Manual backup | Manual crank | Manual crank | Same | | Characteristic | Predicate Device iMRI 3T V K212367 | Proposed Device InVision 1.5 Surgical Theatre | Equivalence Comparison | | Magnet mover covers | Cover components that wrap the magnet mover and are stationary with respect to the mover. | Cover components that wrap the magnet mover and are stationary with respect to the mover. | Same | | Magnet covers | Customized by IMRIS to accommodate the magnet mover, mounted side display, RF/air cover, collision detection system, and mounted docking station. | Customized by IMRIS to accommodate the magnet mover, mounted side display, RF/air cover, collision detection system, and mounted docking station. | Similar | | Intermediate covers | Cover the gap between the magnet covers and the magnet mover covers. | Cover the gap between the magnet covers and the magnet mover covers. | Similar | | Ramp connection assembly | Provides electrical connections and supporting mechanical bracketry to ramp the magnet, custom placement for IMRIS systems. | Provides electrical connections and supporting mechanical bracketry to ramp the magnet, custom placement for IMRIS systems. | Similar | | Intraoperative RF coil connectors | Front of magnet | Front of magnet | Same | | RF switch | Multi-channel double-throw electronic switch, located between the RF slide connectors and the Siemens digital receiver. | Multi-channel double-throw electronic switch, located between the RF slide connectors and the Siemens digital receiver.…