Model 37-185
510(k) K973960
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973960 | Date14 Jan 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LHN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Model 37-185 is a Class II medical device used to scan and compare the light field and radiation field generated by radiation therapy machines. It provides data for quality control purposes, ensuring accurate alignment and calibration of radiation therapy equipment.
The device is supplied as a single-use system and is intended for use in radiology settings. It is not reusable and requires proper storage according to manufacturer guidelines. The device is regulated under 21 CFR 892.5050 and has received FDA 510(k) clearance.
Other devices from Victoreen, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Model 37-185 used for?
The Model 37-185 is used to scan and compare the light field and radiation field generated by radiation therapy machines, providing data for quality control to ensure accurate alignment and calibration of the equipment.
Is the Model 37-185 reusable or single-use?
The Model 37-185 is supplied as a single-use system and is not reusable; it must be discarded after one use to maintain measurement accuracy and prevent cross-contamination.
How should the Model 37-185 be stored?
The Model 37-185 requires proper storage according to manufacturer guidelines to ensure its integrity and performance prior to use in radiology settings.