Cleared Traditional

K921275 - SONY LASER VIDEODISC RECORDING SYSTEM

K921275 is an FDA 510(k) clearance for SONY LASER VIDEODISC RECORDING SYSTEM, manufactured by Sony Medical Systems. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K921275 · Sony Medical Systems · Radiology device
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Jun 1992
Decision
82d
Days
Class 1
Risk

K921275 is an FDA 510(k) clearance for the SONY LASER VIDEODISC RECORDING SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Sony Medical Systems (Attleboro, US). The FDA issued a Cleared decision on June 10, 1992 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sony Medical Systems devices

FDA 510(k) Submission Details - K921275

510(k) Number K921275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1992
Decision Date June 10, 1992
Days to Decision 82 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 107d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 34
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K921275.
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KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
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DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
K905488 · Ausonics Pty , Ltd. · Dec 1991
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
K901118 · Adac Laboratories · Apr 1990