Who is the manufacturer of ASPECT OPTICAM?

Aspect Electronics, Inc. filed the 510(k) submission for ASPECT OPTICAM (K962051).

What is the FDA product code for ASPECT OPTICAM?

LMC. It is classified under 21 CFR 892.2040 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ASPECT OPTICAM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ASPECT OPTICAM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ASPECT OPTICAM

K962051 · Aspect Electronics, Inc. · LMC · Aug 23, 1996 · Radiology

Device Facts

Record ID	K962051
Device Name	ASPECT OPTICAM
Applicant	Aspect Electronics, Inc.
Product Code	LMC · Radiology
Decision Date	Aug 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2040
Device Class	Class 2

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.

Indications for Use

Indicated for the production of monochrome 8" x 10" film copies from medical images stored on magneto-optical disks and the transfer of color images to color film recorders.

Regulatory Classification

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

Related Devices

K011949 — ELK LASER IMAGER, MODEL EL-DRY 4000 · Nishimoto Sangyo Co., Ltd. · Aug 29, 2001
K083522 — SONY UP-DF750 DIGITAL FILM IMAGER · Sony Electronics, Inc. · Jan 9, 2009
K961680 — SONY DKR-700 DIGITAL STILL RECORDER · Sony Medical Systems · Jul 3, 1996
K962364 — CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) · Codonics, Inc. · Nov 8, 1996
K971973 — KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER · Eastman Kodak Company · Aug 25, 1997

Submission Summary (Full Text)

{0} 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.