Cleared Traditional

K780969 - GAMMA CAMERA

K780969 is an FDA 510(k) clearance for GAMMA CAMERA, manufactured by Machlett Laboratories, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K780969 · Machlett Laboratories, Inc. · Radiology device
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Jun 1978
Decision
15d
Days
Class 1
Risk

K780969 is an FDA 510(k) clearance for the GAMMA CAMERA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Machlett Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1978 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Machlett Laboratories, Inc. devices

FDA 510(k) Submission Details - K780969

510(k) Number K780969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1978
Decision Date June 27, 1978
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 90
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K780969.
PROCESSING SYSTEM, A2 IMAGE
K782047 · Medtronic Vascular · Dec 1978
CAMERA, GCA-10A, LOW ENERGY
K781739 · Toshiba Medical Systems · Nov 1978
MAXI-CAMERA 535
K781673 · General Electric Co. · Oct 1978
GAMMA CAMERA
K780855 · G.D. Searle and Co. · Jun 1978
DATA CAMERA
K780491 · General Electric Co. · Apr 1978
GAMMA CAMERAS -GXA-301 & GCA-402
K771599 · Toshiba Medical Systems · Sep 1977