Cleared Traditional

K950610 - FIKO FO

Also marketed or referenced as:
, TJER,A O,AGER FTO-1000

K950610 is the FDA 510(k) clearance for FIKO FO by Fujifilm Medical System U.S.A., Inc.. It is a Class 2 Radiology device (product code LMC) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K950610 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
74d
Days
Class 2
Risk

K950610 is an FDA 510(k) clearance for the FIKO FO. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 Fujifilm Medical System U.S.A., Inc. devices

Submission Details

510(k) Number K950610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1995
Decision Date April 25, 1995
Days to Decision 74 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
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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 - LMC Camera, Multi Format, Radiological

All 33
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K950610.
FUJI MEDICAL DRY IMAGER FM-DP 2636
K962967 · Fujifilm Medical System U.S.A., Inc. · Oct 1996
SIENET TELERADIOLOGY PRODUCT LINE
K955394 · Siemens Medical Solutions USA, Inc. · Feb 1996
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K950721 · Fujifilm Medical System U.S.A., Inc. · May 1995
FUJI MEDICAL LASER IMAGER FL-IM D
K945475 · Fujifilm Medical System U.S.A., Inc. · Mar 1995
PMI100 VIDEO IMAGER
K925220 · Heraeus Kulzer, Inc. · May 1993
PHILIPS LASER DISK ARCHIVE
K923481 · Philips Medical Systems, Inc. · May 1993