← Product Code [LLZ](/productcode/LLZ) · K970813 # DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 (K970813) _Denvu, Inc. · LLZ · May 8, 1997 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K970813 ## Device Facts - **Applicant:** Denvu, Inc. - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** May 8, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures. ## Device Story DIMS (Digital Imaging and Medical System) models CL1-5110/CL1-5111; PACS for colposcopy. System digitizes, displays, processes, stores, and transmits colposcopy images. Hardware sourced from third-party manufacturers; software operates on Windows 95 platform. Used in clinical settings during colposcopy examinations to manage medical imaging data. Assists clinicians in image review and documentation. ## Clinical Evidence No clinical evaluations or comparative performance testing submitted. Bench testing limited to software development process. ## Technological Characteristics PACS system; hardware components sourced from third-party manufacturers; Windows 95 software environment. Functions: image display, processing, digitization, storage, and transmission. Two models distinguished by monitor size. ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - Wallach Digital Imaging System ([K950630](/device/K950630.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} DENVU L.C. 4400 South Santa Rita Avenue Tucson, AZ 85714 K970813 (520) 889-7900 Fax: (520) 741-2200 MAY - 8 1997 510(k) SUMMARY Submitter's name: DenVu L.C. Date summary prepared: February 24, 1997 Device name: Proprietary name: DIMS (Digital Imaging and Medical System), Model CL1-5110 and Model CL1-5111. Common or usual name: Picture archiving and communications system (PACS). Classification name: Proposed classification: Picture archiving and communications systems (PACS), Class II, 21 CFR 892.2050. Legally marketed device for substantial equivalence comparison: Wallach Digital Imaging System submitted by Wallach Surgical Devices, Inc. and cleared for marketing under 510(k) K950630. Description of the device: The DIMS (Digital Imaging and Medical System) is a picture archiving and communications system. Hardware components are purchased from other manufacturers. Two models will be provided, distinguished only by the size of their monitors. Software runs in the Windows 95 format. Intended use of device: The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures. Technological characteristics: The DIMS device can display, process, digitize, store, and transmit images obtained during colposcopy examinations using hardware and software components. Testing conducted: Software testing was conducted as part of the development process. Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k). --- **Source:** [https://fda-staging.innolitics.com/device/K970813](https://fda-staging.innolitics.com/device/K970813) **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