Cleared Traditional

K043287 - PALMSCAN AP2000

Also marketed or referenced as:
PALMSCAN A2000 PALMSCAN P2000

K043287 is an FDA 510(k) clearance for PALMSCAN AP2000, manufactured by Micromedical Devices, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K043287 · Micromedical Devices, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
11d
Days
Class 2
Risk

K043287 is an FDA 510(k) clearance for the PALMSCAN AP2000. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Micromedical Devices, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Micromedical Devices, Inc. devices

FDA 510(k) Submission Details - K043287

510(k) Number K043287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2004
Decision Date December 10, 2004
Days to Decision 11 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Consultant

California Department of Health Services
ALFREDO J QUATTRONE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 683
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K043287.
CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
K050167 · Chison Medical Imaging Co., Ltd. · Feb 2005
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K043563 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
K042620 · Tetrad Corp. · Dec 2004
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
K043275 · Olympus Medical Systems Corporation · Dec 2004
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
K043078 · Toshiba America Medical Systems, In.C · Nov 2004
SENSATOUCH
K042250 · Aluna Management Co., Ltd. · Nov 2004