Cleared Traditional

K850885 - STARCAM DATA ACQUISITION & PROCESSING SYS H3300C

K850885 is an FDA 510(k) clearance for STARCAM DATA ACQUISITION & PROCESSING S..., manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code JWM cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K850885 · General Electric Co. · Radiology device
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Jun 1985
Decision
94d
Days
Class 2
Risk

K850885 is an FDA 510(k) clearance for the STARCAM DATA ACQUISITION & PROCESSING SYS H3300C. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on June 6, 1985 after a review of 94 days - within the typical 510(k) review window.

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 General Electric Co. devices

FDA 510(k) Submission Details - K850885

510(k) Number K850885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1985
Decision Date June 06, 1985
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWM Device Classification - Class 2, Special Controls

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 K850885.
ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM
K874473 · Adac Laboratories · Jul 1988
ADAC MODEL ARC-5000, GAMMA CAMERA
K873075 · Adac Laboratories · Oct 1987
DIGITAL GAMMA CAMERA GCA 601 E
K851685 · Toshiba Medical Systems · Jun 1985
DIGITAL GAMMA CAMERA GCA 501S
K851686 · Toshiba Medical Systems · Jun 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B
K851687 · Toshiba Medical Systems · Jun 1985
DOT-A, DOT-AR PXP-E, PXP-ER
K841905 · Siemens Gammasonics, Inc. · Aug 1984