← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K974455 # ANATOM 1000 (A MINUS, A-) (K974455) _Analogic Corp. · JAK · Feb 20, 1998 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K974455 ## Device Facts - **Applicant:** Analogic Corp. - **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md) - **Decision Date:** Feb 20, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Anatom 1000 system is intended to be used as a diagnostic x-ray device, for the purpose of obtaining cross-sectional images of the whole body by computer reconstruction of X-ray data, from the same axial plane taken at different angles. This device includes signal analysis and display equipment, patient and equipment supports, component parts and accessories. Additionally, the Anatom 1000 system can be field upgraded to either an “A” system or an “HA+” system which includes the capabilities of Helical Scanning (Volumetric scanning) and MPR (Multi-planar Reconstruction). ## Device Story Anatom 1000 is a stand-alone computed tomography (CT) system; utilizes X-ray data acquired at different angles for computer reconstruction of cross-sectional body images. System includes signal analysis/display equipment, patient supports, and accessories. Field-upgradable to support Helical (volumetric) scanning and Multi-planar Reconstruction (MPR). Operated by qualified clinicians/healthcare professionals in clinical environments. Performs automatic system tests at power-up; operator-initiated image quality tests available via control room console. Provides radiologists with CT imaging for diagnostic decision-making. ## Clinical Evidence No clinical data provided. Effectiveness established through verification and validation of software programs and system performance testing during development phases. ## Technological Characteristics Diagnostic X-ray CT system. Components: X-ray source, signal analysis/display equipment, patient support. Standards: UL2601, CSA 22.2 No. 601.1, IEC 601-1, Federal Diagnostic X-ray Equipment Performance Standard. Features: Automatic system power-up test, operator-console image quality test. Upgradable to Helical scanning and MPR. ## 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. ## Related Devices - [K020913](/device/K020913.md) — CT-C3000 SPIRAL CT SCANNER SYSTEM · Neusoft Digital Medical Systems Co., Ltd. · Apr 3, 2002 - [K964890](/device/K964890.md) — ANATOM 2000 · Analogic Corp. · Mar 6, 1997 - [K133590](/device/K133590.md) — SOMATOM PERSPECTIVE · Siemens Medical Solutions USA, Inc. · Apr 30, 2014 - [K072606](/device/K072606.md) — AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM · Toshiba America Medical Systems, In.C · Oct 2, 2007 - [K980837](/device/K980837.md) — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS · Shimadzu Medical Systems · May 20, 1998 ## Submission Summary (Full Text) {0} Summary FEB 20 1998 # Safety: As evident from the enclosed device description, Anatom 1000 is a stand-alone device. It is intended that the system will be operated under the control of qualified clinicians only, while a patient is being examined. The operators should be healthcare professionals familiar with and responsible for the CT studies to be performed. All of the system's X-ray components are certified to be in compliance with the Federal Diagnostic X-ray Equipment Performance Standard. The enclosed device labeling and instructions provide the operator(s) with the knowledge required to safely use the Anatom 1000 system. To minimize electrical and mechanical, as well as radiation hazards, Analogic adheres to FDA GMPs, recognized and established industry practices, and all equipment is subject to final on site performance testing which is carried out by qualified field service engineers. The system will be certified to both national and international safety standards, i.e. UL2601, CSA 22.2 No. 601.1 and IEC 601-1, and other collateral standards for radiation protection, patient support equipment and PEMS. Use of the Anatom 1000 does not contribute any additional risk to the patient or operator, but provides the radiologist with recognized benefits of CT imaging technology. NOTE: An automatic systems test is performed every time the Anatom 1000 system is powered up. In addition, a separate image quality test can be performed from the operator console in the control room before each use. # EFFECTIVENESS: Based on Analogic's evaluation throughout all development phases of the Anatom 1000 system, and verification/validation of software programs involved, the product will perform in accordance with original product development objectives. The Anatom 1000 represents state-of-the-art technology and, therefore, is equivalent to other similar products already cleared by the 510(k) process. At this time, we are unable to find any information regarding any new adverse effects for this type of equipment. A risk assessment and hazards analysis have been ongoing throughout the system's design, development and manufacturing processes which have taken into account older or previously reported problems initially discovered with older designs for this type of equipment. Analogic Corporation Vice President Corporate QA & RA, Customer Service Division Robert H. French (Signature) (Date) November 24, 1997 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Robert H. French Vice President Corporate QA & RA Customer Service Division Analogic Corporation 8 Centennial Drive Peabody, MA 01960 Re: K974455 Anatom 1000 (A minus, A-) Computed Tomography System Dated: November 24, 1997 Received: November 25, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK Dear Mr. French: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Page 1 of 1 510(k) Number (if known): ___________ Device Name: **Anatom 1000** Indications for Use: The Anatom 1000 system is intended to be used as a diagnostic x-ray device, for the purpose of obtaining cross-sectional images of the whole body by computer reconstruction of X-ray data, from the same axial plane taken at different angles. This device includes signal analysis and display equipment, patient and equipment supports, component parts and accessories. Additionally, the Anatom 1000 system can be field upgraded to either an “A” system or an “HA+” system which includes the capabilities of Helical Scanning (Volumetric scanning) and MPR (Multi-planar Reconstruction). (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ☑ (per 21 CFR 801.109) OR over-the-counter Use ☐ (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number **K974455** --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K974455](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K974455) **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. 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