Cleared Traditional

K920721 - DIGITAL RADIOGRAPHY SYSTEM IDR-2000

K920721 is the FDA 510(k) clearance for DIGITAL RADIOGRAPHY SYSTEM IDR-2000 by Shimadzu Medical Systems. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K920721 · Shimadzu Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
57d
Days
Class 2
Risk

K920721 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY SYSTEM IDR-2000. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on April 15, 1992 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Shimadzu Medical Systems devices

Submission Details

510(k) Number K920721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date April 15, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 135
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K920721.
SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES
K922011 · Shimadzu Medical Systems · Jun 1992
SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES
K922013 · Shimadzu Medical Systems · Jun 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-1000
K920720 · Shimadzu Medical Systems · Apr 1992
PEGASUS LATERAL CARDIAC POSITIONER
K915592 · Fischer Imaging Corp. · Jan 1992
FVP-1000 FAMILY AND FVP-1000D FAMILY
K905694 · Fischer Imaging Corp. · Nov 1991
FLUROSPOT H VERSION 2
K914525 · Siemens Medical Solutions USA, Inc. · Nov 1991