Cleared Traditional

K910048 - ECAT SCANNER

K910048 is an FDA 510(k) clearance for ECAT SCANNER, manufactured by Cti Pet Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K910048 · Cti Pet Systems, Inc. · Radiology device
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May 1991
Decision
130d
Days
Class 2
Risk

K910048 is an FDA 510(k) clearance for the ECAT SCANNER. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Cti Pet Systems, Inc. (Knoxville, US). The FDA issued a Cleared decision on May 17, 1991 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cti Pet Systems, Inc. devices

FDA 510(k) Submission Details - K910048

510(k) Number K910048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1991
Decision Date May 17, 1991
Days to Decision 130 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
23d slower than avg
Panel avg: 107d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 290
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K910048.
CIRRUS GAMMA CAMERA
K913471 · Adac Laboratories · Oct 1991
MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM
K913630 · Siemens Gammasonics, Inc. · Oct 1991
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM
K911078 · Siemens Gammasonics, Inc. · Jun 1991
MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
K900892 · Siemens Gammasonics, Inc. · May 1990
DIACAM GAMMA CAMERA SYSTEM
K901019 · Siemens Gammasonics, Inc. · Apr 1990
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
K894056 · Shimadzu Medical Systems · Nov 1989