← Product Code [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS) · K964012 # GENIE PROCESSING AND REVIEW WORKSTATION (K964012) _GE Medical Systems · KPS · Jan 7, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K964012 ## Device Facts - **Applicant:** GE Medical Systems - **Product Code:** [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS.md) - **Decision Date:** Jan 7, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1200 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data. ## Device Story Genie P&R is a UNIX-based workstation for nuclear medicine image management; inputs include digital image data from nuclear medicine cameras via ethernet network; system performs retrieval, archival, processing, and analysis of images; output displayed on high-resolution color monitor; optional hardcopy via laser/color printer; used by physicians in clinical settings to review diagnostic images; facilitates clinical decision-making by providing tools for image visualization and analysis. ## Clinical Evidence No clinical data provided; device functionality is based on established image processing and management capabilities equivalent to the predicate. ## Technological Characteristics UNIX-based workstation; high-resolution color monitor; keyboard/mouse input; ethernet network connectivity; CD-ROM drive; optional optical disk archive and laser/color hardcopy output. ## Regulatory Identification An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. ## Predicate Devices - Starcam 4000 ([K904174](/device/K904174.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} GE Medical Systems JAN - 9 1997 General Electric Company P.O. Box 414, Milwaukee, WI 53201 K964012 # SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 (h). ## Identification Of Submitter JAN - 7 1997 Submitter: Larry A. Kroger, Ph.D GE Medical Systems 3000 N. Grandview Blvd., W-709 Waukesha, WI 53188 Telephone: (414) 544-3894 Fax: (414) 544-3863 Date Of Preparation: September 30, 1996 ## Identification Of The Product Device Proprietary Name: GENIE Processing And Review Workstation (Genie P&R). Common Name: Nuclear Medicine Image Workstation Classification Name: Nuclear Tomography System, 892.1310 Establishment Reg. Number: 2126677 Manufacturing Location: GE Medical Systems 3000 N. Grandview Blvd. Waukesha, WI 53188 ## Marketed Devices | Predicate Device: | System | Manufacturer | 510(k) # | | --- | --- | --- | --- | | | Starcam 4000 | GE Medical Systems | K904174 | ## Device Description Genie P&R is a computer workstation used for the retrieval, archival, processing, analysis and management of nuclear medicine images (data). It consists of a UNIX based workstation (high resolution color monitor, keyboard, mouse, CD ROM), ethernet network connection and system software. Optional optical disk archive and laser filming/color hardcopy are available. ## Indications For Use Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data. {1} Summary Of Safety And Effectiveness Genie Page 2 ## Comparison With Predicate Device Genie P&R and the predicate device can retrieve, archive and process nuclear medicine images. A comparison of the features indicates that Genie P&R has the same intended use as the predicate device. No new safety or effectiveness concerns are raised by the design of Genie P&R. ## Summary Of Studies Genie P&R can retrieve, archive, process, analyze and manage nuclear medicine images. ## Conclusions In the opinion of GE Medical Systems, Genie P&R is substantially equivalent to the Starcam 4000 (image processing system only) manufactured by GE Medical Systems (510(k) # K904174). Genie P&R has the same intended use as the predicate device. No new safety or effectiveness concerns are raised by the design of Genie P&R. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K964012](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K964012) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com