# K092637: Pacscan Plus, Models 300P and 300AP

- Pathway: 510(k) (Special)
- Applicant: Sonomed, Inc.
- Decided: Sep 24, 2009 after 28 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 4000P Pachymeter System: named in the summary without a submission number
- (no number) E-Z Scan 5500+ A-Scan / B-Scan System: named in the summary without a submission number

## Indications for use
The PacScan Plus is Sonomed's newest diagnostic ultrasound system which integrates a contact A-scan system, pachymeter, and analog thermal printer into a single unit for the convenient collection and retention of intraocular measurements. The system's principal application is to serve as an aid in the calculation of the associated IOL power for implanted lenses. As such, the PacScan Plus has been designed to capture key measurements such as axial length, anterior chamber depth and corneal thickness with both accuracy and precision.

Source page: https://510kreport.com/device/K092637
Methodology: https://510kreport.com/methodology