← Back to catalogue

Brymascan-A

FDA 510(k)

Class II (US FDA 510(k))

510(k) K881336

by Brymill Corp.

Identifiers

510(k) Number
K881336 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Brymascan-A is an ultrasonic diagnostic system (Product Code IYO), designed for imaging internal body structures using high-frequency sound waves. It provides real-time visualization to assist in diagnostic evaluations, particularly in radiology applications.

This device is supplied as a reusable medical instrument and requires appropriate sterilization procedures between uses. It was cleared under the FDA’s 510(k) pathway (K881336) with a decision of Substantially Equivalent, filed in 1988 and cleared in 1989. No additional regulatory markings beyond the stated 510(k) clearance are provided in the available data.

Frequently asked questions

What type of imaging does the Brymascan-A perform, and how is it used in clinical settings?

The Brymascan-A is an ultrasonic diagnostic system that uses high-frequency sound waves to create real-time images of internal body structures. Clinicians primarily rely on it in radiology applications to assist with diagnostic evaluations, such as examining organs, tissues, or blood flow. Its real-time visualization capability makes it useful for procedures requiring immediate feedback, like guiding biopsies or monitoring fetal development.

Is the Brymascan-A designed for single-use or reusable applications, and what sterilization steps are required?

The Brymascan-A is not single-use—it is classified as a reusable medical instrument. Since it is intended for repeated use across patients, it must undergo appropriate sterilization procedures between uses to ensure safety and prevent cross-contamination. The manufacturer’s instructions should specify the recommended sterilization method (e.g., autoclave, chemical sterilization).

How was the Brymascan-A approved by the FDA, and what does the ‘Substantially Equivalent’ designation mean?

The Brymascan-A was cleared through the FDA’s 510(k) pathway under the reference number K881336, filed in March 1988 and cleared in March 1989. The ‘Substantially Equivalent’ (SESE) designation means the FDA determined it has the same intended purpose, technological characteristics, and performance as a legally marketed predicate device already on the market. This does not imply it is a new innovation but rather that it meets existing safety and effectiveness standards for radiology diagnostic imaging devices (Product Code IYO).

What regulatory committee reviewed the Brymascan-A, and what does the ‘Radiology’ advisory committee description indicate?

The Brymascan-A was reviewed by the Radiology (RA) Advisory Committee, a panel that advises the FDA on diagnostic imaging devices. The ‘Radiology’ advisory committee description confirms this device falls under the radiology product category, meaning its review focused on ensuring it meets standards for safe and effective imaging of internal body structures using ultrasound technology. This committee helps the FDA assess whether the device aligns with established practices in diagnostic radiology.

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: BRYMASCAN-A (K881336) — FDA 510(k) | Innolitics, BRYMASCAN-A 510 (k) K881336 - FDA.report, Brymill-Corp FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Brymill Corp.

Sources (1)

  • FDA 510(k) K881336 24 fields · synced Sep 19, 2026