Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series

Q: What is the product code of K991282?

The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.

FDA 510(k) K991282 · Seiko Instruments USA, Inc.

Substantially Equivalent

510(k) numberK991282

Submission

Device name: Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series
Applicant: Seiko Instruments USA, Inc.
Aubrey, TX, US
Received: April 14, 1999
Decision date: June 30, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LMC – Camera, Multi Format, Radiological
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2040
Specialty: Radiology

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Questions and answers

When was Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series cleared by the FDA?

Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series (K991282) received a 510(k) decision of Substantially Equivalent on June 30, 1999, 77 days after the submission was received.

What is the product code of K991282?

The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.