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Pocket III

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K232302Ref POCKET III

by Quantel Medical

Identity

Trade Name
POCKET III EUDAMEDFDA UDI
Generic Name
Ultrasound pachymeter FDA UDI
Device Name
POCKET III EUDAMED
The POCKET III unit is an ultrasonic pachymeter intended to be used for the measurement of corneal thickness by ultrasonic means. This measurement is required for refractive surgery and for the diagnosis of glaucoma. FDA UDI
Model / Reference
POCKET III EUDAMEDFDA UDI
Description
The POCKET III unit is an ultrasonic pachymeter intended to be used for the measurement of corneal thickness by ultrasonic means. This measurement is required for refractive surgery and for the diagnosis of glaucoma. FDA UDI

Identifiers

Primary DI / UDI-DI
03700542626009 EUDAMEDFDA UDI
Basic UDI-DI
37005426POCKETIIIBE EUDAMED
510(k) Number
K232302 FDA 510(k)FDA UDI
FDA Product Code
IYO FDA 510(k)FDA UDI
EMDN Code
Z12120116 PACHYMETERS EUDAMED
GMDN Term
Ultrasound pachymeter FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)FDA UDI
Market of Registration
Spain EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Pocket III is a portable ultrasound imaging device designed for real-time diagnostic imaging of internal body structures. Classified under the product code IYO, it is intended for radiologic examination and diagnostic procedures, enabling clinicians to visualize organs, tissues, and blood flow with high-resolution imaging.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as hospitals, outpatient clinics, and emergency departments. It is not classified as MRI-safe or MRI-conditional, and its sterility status is not specified in the provided data. Authorized under FDA 510K clearance and MDR compliance, the Pocket III is intended for professional medical use only, adhering to regulatory standards for diagnostic imaging equipment.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quantel Medical

Sources (3)

  • FDA 510(k) K232302 24 fields · synced Sep 18, 2026
  • FDA UDI ec9535dc-8f2d-4d5a-8398-d4329c1a2b08 34 fields · synced May 30, 2026
  • EUDAMED 5182831c-818d-4990-84d2-a3663c9e1b80 61 fields · synced Jul 9, 2026