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510(k) Data Aggregation
K Number
K043287Device Name
PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000
Manufacturer
MICRO MEDICAL DEVICES, INC.
Date Cleared
2004-12-10
(11 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
MICRO MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collectively, the 3 PalmScan 2000 Devices [i.e., three (3) biometric devices listed below] are each designed as either: a) the PalmScan AP2000 A-Scan/Pachymeter Combination dual mode device [i.e., PalmScan AP2000]; or solely as: b) the PalmScan A2000 A-Scan mode only device [i.e., PalmScan A2000); or as: c) the PalmScan P2000 Pachymeter mode only [i.e., PalmScan P2000] medical device.
The PalmScan AP2000 A-Scan/Pachymeter Combination [i.e., PalmScan AP2000] device is intended as a portable battery operated biometer, which incorporates A-mode pulsed-echo ultrasound technology, and thus is intended be used to accurately measure the axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT) of the human eye. This PalmScan AP2000 device is also intended for calculating the optical power of an intraocular lens (IOL) that is to be implanted during cataract surgery.
The PalmScan A2000 A-Scan [i.e., PalmScan A2000] device is intended as a portable battery operated biometer, which incorporates A-mode pulsedecho ultrasound technology, and thus is intended be used to accurately measure the axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) of the human eye. This PalmScan A2000 device is also intended for calculating the optical power of an intraocular lens (IOL) that is to be implanted during cataract surgery.
The PalmScan P2000 Pachymeter [i.e., PalmScan P2000] device (as well as the combination PalmScan AP2000 device) is intended as a potable battery operated pachymeter, which incorporates A-mode pulsed-echo ultrasound technology, and thus is intended be used to accurately measure the corneal thickness (CT) of the human eye.
Device Description
The PalmScan AP2000 A-Scan/Pachymeter Combination [i.e., PalmScan AP2000] device is a portable, battery operated biometer, which uses A-Mode, pulsed-echo ultrasound technology to measure the axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT) of the human eye. This PalmScan AP2000 device utilizes a Palm Personal Digital Assistant (Palm PDA) for user interface, information display, as well as data processing. This PalmScan AP2000 device non-sterile professional use only device also utilizes a contact and/or immersion ultrasonic transducer to generate pulses and receive their echoes.
The PalmScan A2000 A-Scan [i.e., PalmScan A2000] device is a portable, battery operated biometer, which uses A-Mode, pulsed-echo ultrasound battory operator the axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) of the human eye. This PalmScan A2000 (100), altilizes a Palm Personal Digital Assistant (Palm PDA) for user interface, information display, as well as data processing. This PalmScan A2000 device non-sterile professional use only device also utilizes a contact and/or immersion ultrasonic transducer to generate pulses and receive their echoes.
The PalmScan P2000 Pachymeter [i.e., PalmScan P2000] device is a portable, battery operated biometer, which uses A-Mode, pulsed-echo ultrasound technology to measure the corneal thickness (CT) of the human eye. The PalmScan P2000 device utilizes a Palm Personal Digital Assistant (Palm PDA) for user interface, information display, as well as data processing. This PalmScan P2000 device non-sterile professional use only device also utilizes a contact and/or immersion ultrasonic transducer to generate pulses and receive their echoes.
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