SC1000 Scan Converter

Q: What is the product code of K926348?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.

FDA 510(k) K926348 · Perkins Mfg. Co.

Substantially Equivalent

510(k) numberK926348

Submission

Device name: SC1000 Scan Converter
Applicant: Perkins Mfg. Co.
Dallas, TX, US
Received: December 17, 1992
Decision date: November 19, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: LMB – Device, Digital Image Storage, Radiological
Device class: Class I (low risk)
Regulation: 21 CFR 892.2010
Specialty: Radiology

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

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Questions and answers

When was SC1000 Scan Converter cleared by the FDA?

SC1000 Scan Converter (K926348) received a 510(k) decision of Substantially Equivalent on November 19, 1993, 337 days after the submission was received.

What is the product code of K926348?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.