PacScan Plus Models 300P and 300AP
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092637 FDA 510(k)
- FDA Product Code
- ITX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PacScan Plus Models 300P and 300AP are ophthalmic ultrasound devices designed for imaging ocular structures. These systems combine A-Scan and Pachymeter functionalities to measure intraocular dimensions and corneal thickness, aiding in diagnostic assessments for conditions such as glaucoma, cataract, and refractive surgery planning.
Used primarily in clinical settings, these devices are intended for single-use or reusable applications depending on manufacturer guidelines. The 300P and 300AP models are portable, digital systems with optional thermal printing for recording measurement results. They are regulated under FDA 510K clearance and comply with the Medical Device Directive (MDD), ensuring adherence to safety and performance standards for ophthalmic diagnostic equipment.
Frequently asked questions
What clinical conditions is the PacScan Plus primarily used to assess in patients?
The PacScan Plus Models 300P and 300AP are designed to measure intraocular dimensions and corneal thickness, which helps in diagnosing and planning treatment for conditions like glaucoma, cataracts, and refractive surgeries. These measurements aid clinicians in evaluating eye health and determining appropriate interventions.
How are the PacScan Plus devices intended to be used in terms of single-use versus reusable applications?
The PacScan Plus Models 300P and 300AP are intended for either single-use or reusable applications, depending on the manufacturer’s guidelines. Clinicians should follow Sonomed’s instructions to ensure proper sterilization and maintenance if reusing the device to maintain safety and performance standards.
Are the PacScan Plus devices portable, and do they include any additional features for recording results?
Yes, the PacScan Plus Models 300P and 300AP are portable digital systems. The 300AP model also includes an optional thermal printing feature, allowing clinicians to generate hard copies of measurement results directly from the device.
What regulatory pathways have the PacScan Plus devices undergone, and which standards do they comply with?
The PacScan Plus Models 300P and 300AP have received FDA 510K clearance, confirming they are substantially equivalent to a predicate device. They also comply with the Medical Device Directive (MDD), ensuring they meet safety and performance requirements for ophthalmic diagnostic equipment in regulated markets.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SONOMED, INC. 300AP+ PacScan 300 Plus Ophthalmic Ultrasound, Sonomed PACSCAN 300A, 300P, 300AP Operators Manual | Manualzz, PDF Pacscan Series 300a 300p 300ap A-scan / Pachymeter, Ophthalmic Equipment | Sonomed PacScan Plus 300AP+ (A-Scan & Pachymeter ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K092637 | Class II | Active |
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Manufacturer
- Manufacturer
- Sonomed, Inc.
Sources (2)
- FDA 510(k) K092637 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026