← Product Code [LMC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC) · K962051

# ASPECT OPTICAM (K962051)

_Aspect Electronics, Inc. · LMC · Aug 23, 1996 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K962051

## Device Facts

- **Applicant:** Aspect Electronics, Inc.
- **Product Code:** [LMC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC.md)
- **Decision Date:** Aug 23, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2040
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Intended Use

The Aspect Electronics, Inc. Opticam is a multi format camera used for retrieving medical images stored on magneto optical disk (removable media) and makes monochrome 8" x 10" film copies in a six on one format. It also passes color images to color film recorders via a SCSI bus.

## Device Story

Multi-format camera; retrieves medical images from magneto-optical disks; produces monochrome 8" x 10" film copies (six-on-one format); transfers color images to external color film recorders via SCSI bus. Used in clinical settings; operated by radiology staff. Device utilizes off-the-shelf computer components. Radiologists validate image quality by comparing hard copy output to original CRT displays. No image processing or compression performed. Benefits include creation of permanent hard copy records for clinical review.

## Clinical Evidence

Bench testing only. Image quality validated by radiologists comparing hard copy output to original CRT images. No clinical data or patient studies.

## Technological Characteristics

Multi-format camera; off-the-shelf computer components; IEC 601 certified; CSA marked; FCC Part 18 compliant. Connectivity via SCSI bus. Media input: magneto-optical disk. Output: 8" x 10" monochrome film. No image processing or compression algorithms.

## Regulatory Identification

A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

## Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Predicate Devices

- Camtronics Ltd, MultiCam System 2200

## Submission Summary (Full Text)

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K962051

# SUMMARY STATEMENT OF SAFETY and EFFECTIVENESS

AUG 23 1996

In accordance with the provisions of the Safe Medical Device Act of 1990, Aspect Electronics, Inc. is providing a summary of safety and effectiveness information regarding the Aspect Opticam Film Recorder, Multi Format Camera.

## General Safety and Effectiveness Concerns:

The device labeling contains instructions for use, indications for use and cautions.

The hardware components of the Aspect Opticam are mainly off-the-shelf computer components that have IEC 601 certification. The unit itself currently has the CSA Mark. The computer equipment complies with part 18 of the FCC rules.

## Validation of Effectiveness

Extensive testing of the device has been performed by programmers, by non-programmers and by potential customers. Software used in the device is only used for control purposes and has no bearing on image quality. There is no image processing or compression used with this device. Image quality of the device has been validated by radiologists who compared hard copy images with the original CRT.

## Substantial Equivalence

The Aspect Electronics, Inc. Opticam is a multi format camera used for retrieving medical images stored on magneto optical disk (removable media) and makes monochrome 8" x 10" film copies in a six on one format. It also passes color images to color film recorders via a SCSI bus. The intended use and technological characteristics of the system are similar to the Camtronics Ltd, MultiCam System 2200. Any differences between the Aspect Opticam System and the equivalent device have no significant influence on safety or effectiveness.

It is our conclusion that there is no hardware device or software component that we know of in the Aspect Opticam System whose failure or latent system design flaw would be expected to result in death or injury to a patient.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K962051](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K962051)

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