Cleared Traditional

K854340 - TECHNICARE 720 HPS CT SCANNER

K854340 is an FDA 510(k) clearance for TECHNICARE 720 HPS CT SCANNER, manufactured by Technicare Corp.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K854340 · Technicare Corp. · Radiology device
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Nov 1985
Decision
18d
Days
Class 2
Risk

K854340 is an FDA 510(k) clearance for the TECHNICARE 720 HPS CT SCANNER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Technicare Corp. (Cleveland, US). The FDA issued a Cleared decision on November 15, 1985 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Technicare Corp. devices

FDA 510(k) Submission Details - K854340

510(k) Number K854340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date November 15, 1985
Days to Decision 18 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
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 636
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K854340.
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935 · Toshiba Medical Systems · Dec 1986
CT MAX, CATALOG NO. B7940 HA
K862317 · General Electric Co. · Oct 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · General Electric Co. · Aug 1986
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
K853444 · Toshiba Medical Systems · Nov 1985
OPTICAL DISC UNIT
K852865 · General Electric Co. · Oct 1985
CT 9000
K843927 · General Electric Co. · Dec 1984