Instrumentarium Ulf Mr Imaging System
by Instrumentarium Corp. 2 variants
510(k) K883622
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883622 | Date14 Sep 1988 | 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- Withdrawn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
- LNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Instrumentarium Ulf Mr Imaging System is a nuclear magnetic resonance imaging system used in radiology. It is a Class II medical device.
The system received FDA 510(k) clearance (K883622) on September 14, 1988, and is substantially equivalent to a predicate device. It is manufactured by Instrumentarium Corp. and intended for use in radiology settings.
Other devices from Instrumentarium Corp.
Questions
AI-generated answers, 27 Sep 2026
What is the Instrumentarium Ulf Mr Imaging System used for?
The Instrumentarium Ulf Mr Imaging System is a nuclear magnetic resonance imaging system intended for use in radiology settings, as stated in its device description and FDA 510(k) clearance documentation.
When did the Instrumentarium Ulf Mr Imaging System receive FDA clearance?
The system received FDA 510(k) clearance (K883622) on September 14, 1988, and was determined to be substantially equivalent to a predicate device.
Who manufactures the Instrumentarium Ulf Mr Imaging System?
The Instrumentarium Ulf Mr Imaging System is manufactured by Instrumentarium Corp., as specified in the device data under the manufacturer and applicant fields.