(32 days)
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No
The device description and intended use clearly describe a film projector for viewing cineangiogram film, with no mention of any computational analysis, image processing, or AI/ML technologies.
No
The device is described as a projector intended to view 35mm cineangiogram film, which is a diagnostic function, not a therapeutic one. It facilitates viewing for diagnosis but does not treat any condition.
No.
The device is intended to view 35 mm cineangiogram film, which is a display function rather than a diagnostic one. It assists in viewing existing diagnostic images, but does not perform diagnosis itself.
No
The device description explicitly lists hardware components such as a film projector, viewing hood, cart, duplicator, camera, and remote control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "view 35 mm cineangiogram film." This describes a device used for displaying pre-recorded medical images, not for performing tests on biological samples to diagnose or monitor a condition.
- Device Description: The description details a projector and related components for viewing film. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The information does not include any details about sample types, analytical methods, or performance metrics relevant to diagnostic testing (like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device is for viewing existing images, which falls under the category of medical imaging equipment, not IVD.
N/A
Intended Use / Indications for Use
The CAP-35BIII and the CINE 275 are intended to view 35 mm cineangiogram film.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Vanguard XR-350
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1980 Radiologic table.
(a)
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.(b)
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.
0
APR 28 1997
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
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 view 35 mm cineangiogram film.
2
| 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. | ||
| Depth 27 in. | |||
| Height 24.4 in. | |||
| Weight 132 lb. | Width 20 in. | ||
| Depth 21.3 in. | |||
| Height 20.3 in. | |||
| Weight 66 lb. | Width 26 in. | ||
| Depth 35.5 in. | |||
| Height 29 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 |