← Product Code [IXC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC) · K973115 # ARRIPRO 35 ST/TV (K973115) _Arnold & Richter Cine Technik · IXC · Sep 2, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC/K973115 ## Device Facts - **Applicant:** Arnold & Richter Cine Technik - **Product Code:** [IXC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC.md) - **Decision Date:** Sep 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1890 - **Device Class:** Class 1 - **Review Panel:** Radiology - **Attributes:** 3rd-Party Reviewed ## Intended Use The device is intended to be used for the projection, diagnosis and quantitative evaluation of 35 mm cineradiographic images ## Device Story Arripro 35 St / TV is a 35 mm cine radiographic film projector/viewer. Inputs: 35 mm cine radiographic film. Operation: computer-controlled intermittent film drive system; revolving lamp holder (two 300 W halogen, one 400 W HTI); high-speed shuttle mode for frame localization. Output: projected images on wall or via integrated B&W-CCD-TV camera with motor-driven x-y zoom carriage and focusing. Video output connects to external monitors, recorders, or printers. Used in cathlabs, lecture halls, and consulting rooms by medical professionals. Enables diagnosis and quantitative evaluation of angiographic images; provides flicker-free projection and high-speed film transport. ## Clinical Evidence No clinical data. Bench testing only, focusing on compliance with DIN and EN standards for radiographic film illuminators and electrical safety. ## Technological Characteristics 35 mm film projector with computer-controlled drive system. Features: revolving lamp holder (300W/400W lamps), B&W-CCD-TV camera, motor-driven x-y zoom/focus. Connectivity: video output for monitors/recorders. Standards: DIN 6856 (Parts 1 & 2), DIN 19045, EN 60950, IEC 950, EN 61010-1, EN 55011, EN 60555, EN 50082-2. ## Regulatory Identification A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs. ## Predicate Devices - CAP 35BIII / CINE 275 ([K971128](/device/K971128.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}------------------------------------------------ K973115 p.1 of 2 407 ARNOLD & RICHTER CINE TECHNIK GMBH & CO. BETRIEBS KG TÜRKENSTRASSE 89 · D-80799 MÜNCHEN ARNOLD & RICHTER CINE TECHNIK · POSTFACH 4001 49 · D-80701 MUNCHEN # Summary of Safety and Effectiveness Information for 510 [k] Submission Radiographic film illuminator 3 FP - 2 1997 | General Information: | | |----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Proprietary name: | Arripro 35 St / TV | | Common name: | -- | | Classification Name: | Radiographic film illuminator | | Classification: | Class II | | Classification Number: | | | Intended use: | The device is intended to be used for the projection, diagnosis and quantitative evaluation of 35 mm cineradiographic images | | Legally marketed device: | CAP 35BIII / CINE 275 | | Proprietary Name: | Cineangiogram projector | | Common Name: | -- | | Classification Name: | Class II | | Classification: | | | Classification Number: | K 971128 | | Date of submission: | -- | | DIN-Standards applied for the Arripro 35 St /TV | | | 1. DIN 6856, Part 1
Demands for the manufacture and the operation | 6. EN 60950
IEC 950 | | | Demands for the manufacture and the operation
of viewing apparatus for the evaluation of
transparent images in medical diagnostics. | | - IEC 950
- DIN EN 60950
- VDE 0805 | |----|-------------------------------------------------------------------------------------------------------------------------------------------|----|-------------------------------------------| | 2. | DIN 6856, Part 2
Quality-guaranteeing measures in medical
diagnostics,
- testing procedures, measuring instruments | 7. | EN-61010-1 | | 3. | DIN 19045, Part 8
Projection of still pictures and motion pictures
for educational and home use. | 8. | EN-60555-2 | | 4. | EN 55011
- CISPR 11 | 9. | EN 60555-3 | - DIN NDE 0875-TI I - VDE 0875-TII ડ. EN 50082-2 - DIN EN 20082-2 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for ARRI, a motion picture technology company. The logo is in black and white and features the company name in bold, sans-serif letters. To the right of the name is a small circle with the letters "ARR" inside. K4 73115 p. 2 of 2 ## Technological Characteristics and the intended use of the device The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images. The ARRIPRO 35 St / TV has the following functions: ### Rapid Film Transport and Simple Operation Film transport via a patented internittent film drive system enables a film transport interval of less than 0.01 sec. regardless of projection speed. Constant film tension and reliable film transport is guaranteed through the use of a computer-controlled drive system for the film platter motors. Film loading is both fast and simple as a result of the computer-controlled system. #### Optimized Image Quality with Flicker Free Projection Image brightness, frame steadiness and image clarity have been optimized for all applications. #### High Speed Shuttle High speed winding and quick localization of specific film frames is accomplished by using the projector's high speed shuttle mode. #### Revolving Lamp Holder The ARRIPRO 35 is equipped with a revolving lamp holder containing three (3) lamps, two (2) 300 W halogen lamps and one (1) 400 W HTI-lamp for bright wall projection. #### Optimum Wall Projection The ARRIPRO 35 also functions as an excellent quality wall projection unit. #### Computer and Video Connections A video output enables the connection of additional monitors, video recorder and video printer. #### B&W-CCD-TV Camera B& W-CCD-TV camera with motor-driven x-y zoom carriage as well as motor driven focusing. TV-image can be panned in all directions and zoomed up to 3.0 times. #### DIN-Standards applied for the Arripro 35 St /TV | 1. | DIN 6856, Part 1
Demands for the manufacture and the operation
of viewing apparatus for the evaluation of
transparent images in medical diagnostics. | 5. | EN 60950
- IEC 950
- DIN EN 60950
- VDE 0805 | |----|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-------------------------------------------------------| | 2. | DIN 6856, Part 2
Quality-guaranteeing measures in medical
diagnostics,
- testing procedures, measuring instruments | 6. | EN-61010-1 | | 3. | DIN 19045, Part 8
Projection of still pictures and motion pictures
for educational and home use. | 7. | EN-60555-2 | | 4. | EN 55011
- CISPR 11
- DIN VDE 0875-T11
- VDE 0875-T11 | 8. | EN 60555-3 | | | | 9. | EN 50082-2
- DIN EN 50082-2
- VDE 839-T82-2 | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arnold & Richter Cine Technik GmbH & Co. Betriebs KG c/o Carole Stamp TUV Product Service ... 1775 Old Highway 8 New Brighton, MN 55112-1891 Re: K973115 Arrioro 35 St / TV (35 mm film viewer) Dated: August 18, 1997 Received: August 20, 1997 Regulatory Class: I 21 CFR 892.1890/Procode: 90 LXC SEP - 2 1397 Dear Ms. Stamp: 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 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 (OS) 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 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". Sincereiv yours h.J. Liao Yin 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 {3}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Radiographic Film Illuminator Indications For Use: The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography. The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system. The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals. (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, ENT, and Radiologigel Du Radiological Devices 510(k) Number_k972115 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-7 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC/K973115](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXC/K973115) **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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