Question 1

Who is the manufacturer of SONOLAYER-L, SAL-77A?

Accepted Answer

Toshiba Medical Systems filed the 510(k) submission for SONOLAYER-L, SAL-77A (K852090).

Question 2

What is the FDA product code for SONOLAYER-L, SAL-77A?

Accepted Answer

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

Question 3

When was SONOLAYER-L, SAL-77A cleared by the FDA?

Accepted Answer

Dec 2, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for SONOLAYER-L, SAL-77A?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like SONOLAYER-L, SAL-77A?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K852090
Device Name	SONOLAYER-L, SAL-77A
Applicant	Toshiba Medical Systems
Product Code	ITX · Radiology
Decision Date	Dec 2, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

SONOLAYER-L, SAL-77A

Device Facts

Regulatory Classification

Identification