Cleared Traditional

K874473 - ADAC MODEL ARC-ST

K874473 is the FDA 510(k) clearance for ADAC MODEL ARC-ST by Adac Laboratories. It is a Class 2 Radiology device (product code JWM) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K874473 · Adac Laboratories · Radiology device
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Jul 1988
Decision
259d
Days
Class 2
Risk

K874473 is an FDA 510(k) clearance for the ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 259 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1310 - 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 Adac Laboratories devices

Submission Details

510(k) Number K874473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date July 18, 1988
Days to Decision 259 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
152d slower than avg
Panel avg: 107d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWM System, Tomographic, Nuclear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1310
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 - JWM System, Tomographic, Nuclear

All 14
Devices cleared under the same product code (JWM) and FDA review panel - the closest regulatory comparables to K874473.
ICON COMPUTER SYSTEM
K914350 · Siemens Gammasonics, Inc. · Nov 1991
ICON
K903315 · Siemens Gammasonics, Inc. · Jan 1991
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
K901545 · Toshiba America Medical Systems, In.C · Jun 1990
ADAC MODEL ARC-5000, GAMMA CAMERA
K873075 · Adac Laboratories · Oct 1987
DIGITAL GAMMA CAMERA GCA 601 E
K851685 · Toshiba Medical Systems · Jun 1985
STARCAM DATA ACQUISITION & PROCESSING SYS H3300C
K850885 · General Electric Co. · Jun 1985