← Product Code [IXR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR) · K971128 # CAP-35B III/CINE 275 (K971128) _Jamieson Film Co. · IXR · Apr 28, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K971128 ## Device Facts - **Applicant:** Jamieson Film Co. - **Product Code:** [IXR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR.md) - **Decision Date:** Apr 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1980 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The CAP-35BIII and the CINE 275 are intended to be used to view 35 mm cineangiogram film. ## Device Story CAP-35BIII and CINE 275 are 35 mm cineangiogram projectors used to display medical film for clinical review. CAP-35BIII features continuous film transport via 16-facet rotating prism, halogen light source, and variable speed projection (3-100 fps); includes viewing hood, cart, remote control, slide camera, and optional TV camera. CINE 275 is a simplified version with manual focus/framing and 3-80 fps projection. Devices are operated by clinicians to view angiographic images, facilitating diagnostic assessment of cardiovascular structures. Output is a projected image on a viewing hood; assists physicians in evaluating patient anatomy and pathology. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics 35 mm film projectors using halogen lamp light sources. CAP-35BIII utilizes continuous film advance with 16-facet rotating prism; CINE 275 uses similar transport. Dimensions: CAP-35BIII (24x24.4x27 in, 132 lb); CINE 275 (20x20.3x21.3 in, 66 lb). Power: 120V 60Hz. Optics: varifocal or fixed lenses. No software or digital algorithms; purely mechanical/optical projection system. ## Regulatory Identification A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9. ## Predicate Devices - Vanguard XR-350 (October 5, 1995) ## 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} APR 28 1997 K971128 # Summary of Safety and Efficacy 510(k) Summary for the CAP-35BIII and CINE 275 Cineangiogram Projectors Prepared February 6, 1997 This summary of 510(k) safety and efficacy information is being submitted in compliance with the requirements of SMDA 1990 and CFR 807.92. ## Submitter's Name Jamieson Film Company 10425 Olympic Dr. Dallas, TX 75220-4427 Contact: Gary Fuller, President Phone: (214) 350-1283 Fax: (214) 357-2170 CAP-35BIII and CINE 275 510(k) Notification 510(k) Summary Page 1 of 3 {1} # Device Name and Classification Trade name: CAP-35BIII and CINE 275 Cineangiogram Projectors Common name: 35 mm Cineangiogram Projector Classification: Angiographic X-Ray System, 21 CFR 892.1600 # Predicate Device The CAP-35BIII and CINE 275 projectors are substantially equivalent to the Vanguard XR-350 cineangiogram projector manufactured which was declared substantially equivalent on October 5, 1995. # Description of the CAP-35BIII and CINE 275 Cineangiogram Projectors The CAP-35BII cineangiogram projector is a continuous film transport 16-facet rotating prism projectors. The CINE 275 is a simpler version of the CAP-35BIII, with fewer options. The CAP-35BIII consists of a 35 mm film projector with built-in viewing hood, a movable cart, a sheet film duplicator, a 35 mm slide camera, a remote control, and an optional TV camera assembly. The CINE 275 consists of a 35 mm film projector with built-in viewing hood and a movable cart. # Intended Use The CAP-35BIII and the CINE 275 are intended to be used to view 35 mm cineangiogram film. CAP-35BIII and CINE 275 510(k) Notification 510(k) Summary {2} Table of Comparisons between the CAP-35BIII, CINE 275, and Vanguard XR-350 | Characteristic | CAP-35BIII | CINE 275 | Vanguard XR-350 | | --- | --- | --- | --- | | Intended use | Viewing 35 mm angiographic film | Viewing 35 mm angiographic film | Viewing 35 mm angiographic film | | Major system components | Projector Cart Remote control 35 mm slide film camera 8" X 10" camera | Projector | Projector Viewing hood Powered mobile cart | | Options | CCD TV camera | Cart | NTSC TV camera | | Light source | Halogen lamp | Halogen lamp | Xenon arc lamp | | Film transport | Continuous film advance, 16-facet rotating prism | Continuous film advance, 16-facet rotating prism | Intermittent claw advance | | Projector dimensions | Width 24 in. Height 24.4 in. Depth 27 in. Weight 132 lb. | Width 20 in. Height 20.3 in. Depth 21.3 in. Weight 66 lb. | Width 26 in. Height 29 in. Depth 35.5 in. Weight 147 lb. | | Power | 120 V 60 Hz 5 A | 120 V 60 Hz 4.5 A | 115 V 60 Hz 10 A | | Film capacity | 35 mm X 656 ft. | 35 mm X 500 ft. | 35 mm X 500 ft. | | Projection optics | 57-92 mm lens f/4.5 varifocal | 50 mm lens f/4.5 | 65 mm lens f/3.0 | | Image size | 11 in. x 8.1 in | 10 in. x 8 in | 11.25 in. x 9.50 in. | | Modes of operation | Variable speed from 3-100 fps Single-frame advance Forward/reverse Rewind Fast forward | Variable speed from 3-80 fps Single-frame advance Forward/reverse Rewind Fast forward | Variable speed: 1, 4, 7, 10, 15, 30 fps Single-frame advance Forward/reverse Rewind Fast forward | | Features | Push-button focus Push-button framing Push-button trimming Push-button zoom LED frame counter Selectable auto-stop | Manual focus Manual framing Selectable auto-stop | Push-button focus Manual framing LED frame counter Auto-stop Image rotation | CAP-35BIII and CINE 275 510(k) Notification 510(k) Summary Page 3 of 3 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K971128](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXR/K971128) **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