Question 1

Who is the manufacturer of PGK STEREOTACTIC DEVICE?

Accepted Answer

Northern Virginia Radiology and Nuclear Medicine filed the 510(k) submission for PGK STEREOTACTIC DEVICE (K911974).

Question 2

What is the FDA product code for PGK STEREOTACTIC DEVICE?

Accepted Answer

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

Question 3

When was PGK STEREOTACTIC DEVICE cleared by the FDA?

Accepted Answer

Nov 5, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for PGK STEREOTACTIC DEVICE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PGK STEREOTACTIC DEVICE?

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	K911974
Device Name	PGK STEREOTACTIC DEVICE
Applicant	Northern Virginia Radiology and Nuclear Medicine
Product Code	HRX · Orthopedic
Decision Date	Nov 5, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

PGK STEREOTACTIC DEVICE

Device Facts

Regulatory Classification

Identification