Cleared Traditional

K921527 - STATVIEW

K921527 is an FDA 510(k) clearance for STATVIEW, manufactured by Image Data Corp.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K921527 · Image Data Corp. · Radiology device
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Jun 1992
Decision
82d
Days
Class 1
Risk

K921527 is an FDA 510(k) clearance for the STATVIEW. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Image Data Corp. (San Antonio, US). The FDA issued a Cleared decision on June 24, 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 892.2020 - 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 Image Data Corp. devices

FDA 510(k) Submission Details - K921527

510(k) Number K921527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1992
Decision Date June 24, 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.

LMD Device Classification - Class 1, General Controls

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
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 - LMD System, Digital Image Communications, Radiological

All 80
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K921527.
DIGITAL IMAGE COMMUNICATIONS SYSTEM
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KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K931551 · Eastman Kodak Company · Jun 1993
SIENET CAMERA SERVER
K923582 · Siemens Gammasonics, Inc. · Oct 1992
3M DIGITAL DISK INTERFACE UNIT
K920268 · 3M Company · May 1992
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
K920310 · Siemens Gammasonics, Inc. · Mar 1992
PHILIPS TELESCAN
K911773 · Philips Medical Systems, Inc. · Jun 1991