Question 1

Who is the manufacturer of EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE?

Accepted Answer

Hitachi Medical Corp. of America filed the 510(k) submission for EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE (K890531).

Question 2

What is the FDA product code for EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE?

Accepted Answer

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

Question 3

When was EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE cleared by the FDA?

Accepted Answer

Apr 13, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE?

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	K890531
Device Name	EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE
Applicant	Hitachi Medical Corp. of America
Product Code	ITX · Radiology
Decision Date	Apr 13, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE

Device Facts

Regulatory Classification

Identification