Cleared Traditional

K880529 - CEILING MOUNTED TILTING TABLE TANGENT III

K880529 is an FDA 510(k) clearance for CEILING MOUNTED TILTING TABLE TANGENT III, manufactured by Fischer Imaging Corp.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K880529 · Fischer Imaging Corp. · Radiology device
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Mar 1988
Decision
23d
Days
Class 2
Risk

K880529 is an FDA 510(k) clearance for the CEILING MOUNTED TILTING TABLE TANGENT III. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on March 3, 1988 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Fischer Imaging Corp. devices

FDA 510(k) Submission Details - K880529

510(k) Number K880529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date March 03, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IXR Table, Radiographic, Tilting

All 47
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K880529.
TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE
K892226 · Tecnomed, Inc. · Apr 1989
GENESIS 180
K883863 · Fischer Imaging Corp. · Oct 1988
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · General Electric Co. · May 1988
OMNI DIAGNOST
K874113 · Xre Corp. · Nov 1987
TRAUMA TABLE II
K874114 · Xre Corp. · Nov 1987
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986