CAP-35B III/CINE 275

K971128 · Jamieson Film Co. · IXR · Apr 28, 1997 · Radiology

Device Facts

• Record ID: K971128
• Device Name: CAP-35B III/CINE 275
• Applicant: Jamieson Film Co.
• Product Code: IXR · Radiology
• Decision Date: Apr 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1980
• Device Class: Class 2

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.

Indications for Use

Indicated for viewing 35 mm cineangiogram film in a clinical setting.

Regulatory Classification

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)

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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: [phone]
Fax: [phone]

CAP-35BIII and CINE 275 510(k) Notification
510(k) Summary
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# 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

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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
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