Cleared Traditional

K921112 - FUJI COMPUTED RADIOGRAPHY OD-F623 OPTIC...

K921112 is the FDA 510(k) clearance for FUJI COMPUTED RADIOGRAPHY OD-F623 OPTIC... by Fujifilm Medical System U.S.A., Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 414-day FDA review.

K921112 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
414d
Days
Class 2
Risk

K921112 is an FDA 510(k) clearance for the FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on April 27, 1993 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Fujifilm Medical System U.S.A., Inc. devices

Submission Details

510(k) Number K921112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date April 27, 1993
Days to Decision 414 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
307d slower than avg
Panel avg: 107d · This submission: 414d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K921112.
BUCKY STAND BR-10M
K942792 · Shimadzu Corp. · Jul 1994
DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR
K941931 · Victoreen, Inc. · May 1994
SHIMADZU CEILING TUBE SUPPORT CH-30GX
K934005 · Shimadzu Corp. · Nov 1993
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · Hologic, Inc. · Oct 1991
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · Medrad, Inc. · Nov 1988
MTX GENERATOR
K880352 · Philips Medical Systems (Cleveland), Inc. · Jul 1988