Cleared Traditional

K772283 - RX PEDESTAL TABLE

K772283 is an FDA 510(k) clearance for RX PEDESTAL TABLE, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K772283 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1977
Decision
3d
Days
Class 2
Risk

K772283 is an FDA 510(k) clearance for the RX PEDESTAL TABLE. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1977 after a review of 3 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 General Electric Co. devices

FDA 510(k) Submission Details - K772283

510(k) Number K772283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1977
Decision Date December 15, 1977
Days to Decision 3 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
104d faster than avg
Panel avg: 107d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZZ Device Classification - Class 2, Special Controls

Product Code IZZ Table, Radiographic, Non-tilting, Powered
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 - IZZ Table, Radiographic, Non-tilting, Powered

All 19
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K772283.
TANGENT II
K883974 · Fischer Imaging Corp. · Oct 1988
VRT TABLE
K827928 · General Electric Co. · Sep 1982
HORIZONTAL RADIOGRAPHIC 4/WAY FLOATING
K792169 · Bennett X-Ray Corp. · Dec 1979
X-RAY REMOTE CONTROL TABLE
K771601 · Toshiba Medical Systems · Sep 1977
RADIAL TRAVEL SPEC. PROCEDURES TABLE
K761339 · Xre Corp. · Jan 1977