NCSClass II

System, Imaging, Holography, Acoustic

21 CFR 892.1550 / Radiology

NCS is the FDA product code for System, Imaging, Holography, Acoustic, a class II device type, regulated under 21 CFR 892.1550. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2002-05-10, and no recalls.

Classification record

Product code: NCS
Device name: System, Imaging, Holography, Acoustic
Regulation: 21 CFR 892.1550
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code NCS

By decision year

3 clearances under product code NCS with a decision year between 2000 and 2002, 2000 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NCS by decision year
Year	Clearances
2000	1
2001	1
2002	1

Applicants with the most clearances

Product code NCS

Applicants holding the most 510(k) clearances under product code NCS
Applicant	Clearances
Advanced Diagnostics, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NCS.

Recent clearances

Product code NCS

Recent recalls

Product code NCS

FDA records show no recalls under product code NCS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)