← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K964318 # PHILIPS TOMOSCAN AV EXPANDER UPGRADE (K964318) _Philips Medical Systems North America, Inc. · JAK · Jan 10, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K964318 ## Device Facts - **Applicant:** Philips Medical Systems North America, Inc. - **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md) - **Decision Date:** Jan 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Device Story Philips TOMOSCAN AVE Upgrade is a hardware/software enhancement package for the Tomoscan SR 7000 CT system. Components include Rapidview Reconstructor and interface package. Enables 7 mm slice thickness and table speeds of 7 and 14 mm/sec. System utilizes X-ray tube and detectors to acquire CT data. Reconstructor facilitates 1-second image reconstruction. Used in clinical radiology settings by trained technicians/radiologists. Output consists of reconstructed CT images for diagnostic interpretation. Upgrade maintains original intended use of the host SR 7000 system; does not alter clinical applications or effectiveness. ## Clinical Evidence Bench testing only. No clinical data provided. Compliance with 21 CFR Part 1020.33, IEC-601, and UL-187 standards cited. ## Technological Characteristics Upgrade package includes Rapidview Reconstructor and interface package. Enables 7 mm slice thickness and table speeds of 7/14 mm/sec. Complies with 21 CFR Part 1020.33, IEC-601, and UL-187. Hardware/software integration with existing SR 7000 CT system. ## Regulatory Identification A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Predicate Devices - TOMOSCAN AVE CT system ([K954255](/device/K954255.md)) - Tomoscan SR 7000 ([K924082](/device/K924082.md)) ## Reference Devices - SR8000 ## 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} PHILIPS PHILIPS JAN 10 1997 Philips Medical Systems K964318 # Summary of Safety and Effectiveness CLASSIFICATION NAME: Computed Tomography X-ray System Class II -21 CFR 892.1750 COMMON/USUAL NAME: CT X-ray System TRADE/PROPRIETARY NAME: Philips TOMOSCAN AVE Upgrade ESTABLISHMENT No. 1217116 PERFORMANCE STANDARDS: 21 CFR Part 1020.33, IEC-601, and UL-187. # SYSTEM DESCRIPTION: The Philips Tomoscan AV Expander Upgrade is an upgrade package to be installed on the existing Tomoscan SR 7000 (K924082). It is comprised of components and capabilities taken from the TOMOSCAN AVE CT system which has been cleared for commercial distribution by Premarket Notification submission K954255. Identified components of the Expander Upgrade are the Rapidview Reconstructor, and an interface package; the included capabilities include a 7 mm slice thickness, and table speeds of 7 and 14 mm/sec. The AV Expander Upgrade does not alter the intended use of the CT system to which it is attached, nor does it differ from the SR8000. The resultant changes in specification do not affect clinical applications or effectiveness of the device. The X-ray tube and the different detectors will be the major difference between an upgraded SR 7000 and the Tomoscan AVE (SR 8000). The AVE Upgrade is intended to address the primary operational differences between the Tomoscan SR 8000 and SR 7000: | Hardware/Software Content | Functional Changes | | --- | --- | | -Rapidview Reconstructor | -1 sec reconstruction | | -Interface package (Net Interface) | -7 mm slice thickness, | | | -Table speeds of 7 and 14 mm/sec | # SAFETY INFORMATION: Computed Tomography is a mature technology with which the industry and users have many years of experience. These devices must comply with the appropriate sections of the Radiation Control for Health and Safety Act. A Product Report will be submitted prior to first delivery. Additionally, Philips CT systems are designed to be in compliance with National and International safety standards. Philips Medical Systems North America Company 710 Bridgeport Avenue Shelton, CT 06484-4708 Tel: (203) 926-7674 Fax: (203) 929-6099 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K964318](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K964318) **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