LHOClass I

Instrument, Quality-Assurance, Radiologic

21 CFR 892.1940 / Radiology

LHO is the FDA product code for Instrument, Quality-Assurance, Radiologic, a class I device type, regulated under 21 CFR 892.1940. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 2004-11-15, and 2 recalls.

Classification record

Product code: LHO
Device name: Instrument, Quality-Assurance, Radiologic
Regulation: 21 CFR 892.1940
Device class: Class I
Review panel: Radiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 8
Ingested recalls: 2

Clearances, product code LHO

By decision year

8 clearances under product code LHO with a decision year between 1984 and 2004, 1986 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code LHO by decision year
Year	Clearances
1984	1
1985	2
1986	3
1987	1
2004	1

Applicants with the most clearances

Product code LHO

Applicants holding the most 510(k) clearances under product code LHO
Applicant	Clearances
Victoreen, Inc.	3
Radiation Measurements, Inc.	2
Varian Assoc., Inc.	2
Standard Imaging Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 57 companies shown, in name order