# K043287: Palmscan AP2000; Palmscan A2000; Palmscan P2000

- Pathway: 510(k) (Traditional)
- Applicant: Micromedical Devices, Inc.
- Decided: Dec 10, 2004 after 11 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913067 (1992). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913067: DGH-4000 a-Scan/Pachymeter, Dgh Technology, Inc. (1992) Summary page 1.

## Most influential descendants
- K063472: Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200 (2007), 2 descendants of its own
- K121243: Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter (2013), 1 descendant of its own
- K152318: MD-2300S Ultrasonic A/B Scanner for Ophthalmology (2015), 0 descendants of its own

## Indications for 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 pulsed-echo 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 comeal thickness (CT) of the human eye. Each of the 3 PalmScan 2000 Devices [i.e., PalmScan AP2000 combination device; PalmScan A2000 A-Scan device; and/or PalmScan P2000 pachymeter device] is intended to be used solely by qualified medical professionals. Clinical considerations and professional judgment should be applied when using this or any other testing device used for patient diagnosis or treatment.

Source page: https://510kreport.com/device/K043287
Methodology: https://510kreport.com/methodology