← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K082964 # PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) (K082964) _Prism Clinical Imaging, Inc. · LNH · Mar 9, 2009 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K082964 ## Device Facts - **Applicant:** Prism Clinical Imaging, Inc. - **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md) - **Decision Date:** Mar 9, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use Prism Acquire® / Prism Process® software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion. Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments. ## Device Story Prism Acquire, Process, and View software suite facilitates fMRI and advanced MRI studies. Prism Acquire presents synchronized visual/auditory stimuli or cognitive/motor tasks to patients during MRI scanning; captures patient responses and raw image data. Prism Process performs post-processing and quality control on acquired data. Prism View enables visualization and integration of anatomical, functional, and physiologic datasets (BOLD fMRI, MRS, perfusion, diffusion/DTI). Used in clinical settings by trained physicians to assist in CNS pathology diagnosis and treatment planning. Prism Flow server-based software manages DICOM communications, authentication, and audit logging. System provides flexible display, analysis, and export options for clinical imagery. ## Clinical Evidence Bench testing only. Software verification and validation conducted to confirm proper function of device features. ## Technological Characteristics Software-based system for MRI data acquisition, processing, and visualization. Supports DICOM standard communications. Integrates with MRI scanners for BOLD fMRI, MRS, perfusion, and diffusion (DTI) data. Operates within healthcare IT environment via server-based infrastructure (Prism Flow). ## 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 - BrainAcquireRx™ ([K061255](/device/K061255.md)) - BrainProcessRx™ ([K061255](/device/K061255.md)) - BrainViewRx™ ([K052467](/device/K052467.md), [K063031](/device/K063031.md)) - Syngo® Multimodality Workstation ([K010938](/device/K010938.md)) - Advantage Windows with FuncTool Option ([K960265](/device/K960265.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word "prism" in lowercase letters with a registered trademark symbol next to it. Above the word is a geometric shape that looks like a triangle with another triangle inside of it. The inner triangle is rotated and slightly offset from the outer triangle, creating a three-dimensional effect. ### 5 510(k) Summary # K082964 – Prism Acquire®, Prism Process®, Prism View® #### 1. Contact Information | Submitter | | Contact Person | |---------------------------------|-------|-----------------------------| | Prism Clinical Imaging, Inc. | | James L. Reuss, Ph.D. (CTO) | | 10437 Innovation Dr., Suite 403 | Phone | 414-727-1930 | | Wauwatosa, WI 53226 | Fax | 414-727-1939 | Date Summary Prepared: September 29, 2008; rev. February 13, 2009 #### 2. Device Name and Classification | Trade Name | Classification Name | Class | Product Code | |---------------|----------------------------------------------------------------|-------|--------------| | Prism Acquire | 892.1000, "Radiology, Magnetic
Resonance Diagnostic Device" | II | LNH | | Prism Process | 892.1000, "Radiology, Magnetic
Resonance Diagnostic Device" | II | LNH | | Prism View | 892.2050, "Picture archiving and
communications systems" | II | LLZ | #### 3. Identification of Legally Marketed Equivalent Predicate Devices | Predicate System | Manufacturer | Reg. Data | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | BrainAcquireRx™,
BrainProcessRx™ | Prism Clinical Imaging, Inc.
10437 Innovation Dr., Suite 403
Wauwatosa, WI 53226
(f/k/a Kyron Clinical Imaging) | K061255
SE 6/13/2006
Product code LNH
Class II | | BrainViewRx™
(a/k/a Prism View) | Prism Clinical Imaging, Inc.
10437 Innovation Dr., Suite 403
Wauwatosa, WI 53226
(f/k/a Kyron Clinical Imaging) | K052467, K063031
SE 12/20/05,11/2/06
Product code LLZ
Class II | | Syngo® Multimodality
Workstation | Siemens Medical Systems
186 Wood Ave. South
Iselin, NJ 08830 | K010938
SE 6/26/2001
Product code LLZ
Class II | | Advantage Windows with
FuncTool Option | GE Medical Systems
3000 N. Grandview Blvd
Waukesha, WI 53188 | K960265
SE 7/3/1996
Product code LLZ
Class II | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a logo with a geometric shape and the word "prism". The geometric shape is a triangle with a smaller triangle inside it, and the inner triangle is filled with a textured pattern. The word "prism" is written in lowercase letters below the triangle, and there is a small circle with an "r" inside it to the upper right of the word, indicating a registered trademark. #### 4. Description of Device Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships. These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions. #### 5. Statement of Intended Use Prism Acquire® / Prism Process® software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion. Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, vields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the word "prism" in lowercase letters with the registered trademark symbol next to it. Above the word is a geometric shape that resembles a triangle with internal lines and a shaded area. The shape is positioned above and slightly to the left of the word "prism". #### Predicate Device Comparison of Technological Characteristics 6. The technological characteristics of Prism Acquire, Process and View are the same as the respective original devices. Incremental revisions to the software have been made, including adoption of DICOM standard communications. The MR perfusion capability added to the indications for use is substantially equivalent to the corresponding features found in the Neuro Perfusion option of the syngo® predicate device, and the GE Advantage workstation with FuncTool option. #### 7. Performance Study FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features. #### Safety information 8. No new safety hazards are introduced by the use of the device in comparison to the software of the predicate devices. {3}------------------------------------------------ # 5 510(k) Summary Image /page/3/Picture/1 description: The image shows the logo for Prism. The logo consists of a geometric shape above the word "prism". The geometric shape is a triangle with another triangle inside of it. The word "prism" is in lowercase letters, and there is a circled R symbol to the right of the word. : {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services (USA). The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. In the center of the seal is an abstract image of a bird-like figure. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAR - 9 2009 James L. Reuss. Ph.D. Chief Technology Officer Prism Clinical Imaging, Inc. 10437 Innovation Dr., Suite 403 WAUWATOSA WI 53226 Re: K082964 Trade/Device Name: Prism Acquire®, Prism Process® and Prism View Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 13, 2009 Received: February 20, 2009 # Dear Dr. Reuss: 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 such 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. {5}------------------------------------------------ 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 this letter. | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 | |----------------|----------------------------------|----------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 | | 21 CFR 892.xxx | (Radiology) | (240) 276-0120 | | Other | | (240) 276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html. Sincerely yours, Janine M. Morris anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ ### Indications For Use 4 # 510(k) Number (if known): KCB 2964 Prism Acquire®, Prism Process®, Prism View® Device Name: # INDICATIONS FOR USE: Prism Acquire® / Prism Process software is used in conjunction with a Magnetic Resorance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (MRI) and other MRI data sets. Prism View software provides visualization of anatomical with functional and physiologic imaging data sets. Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRJ scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion. Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments. Prescription Use X (Per 21 CFR 801 Subpart D) OR Over-the-Counter Use (Per 21 CFR 801 Subpart C) (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 | K082964 | Prism Clinical Imaging, Inc. 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