FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BO POWER SUPPLY
K Number: K921046
·
Decision May 28, 1992
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
21
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BO POWER SUPPLY
- K Number
- K921046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Resonex, Inc.
- Date Received
- March 4, 1992
- Decision Date
- May 28, 1992
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNH), ordered by most recent decision date.
uMR Astra
FDA 510(k)
FDA Class 2
·Radiology
APERTO Lucent MRI System
FDA 510(k)
FDA Class 2
·Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
S-scan Open (100001800)
FDA 510(k)
FDA Class 2
·Radiology
nordicAudio (1.0)
FDA 510(k)
FDA Class 2
·Radiology
Embrace Neonatal MRI System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Resonex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935369 | FAST SPIN ECHO (FSE) | Mar 21, 1994 | Substantially Equivalent |
| K935570 | NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM | Mar 16, 1994 | Substantially Equivalent |
| K931392 | ECG GATING UNIT | Nov 2, 1993 | Substantially Equivalent |
| K923870 | 3DTOF MRA | Jan 12, 1993 | Substantially Equivalent |
| K924154 | KINEMATIC MRI MOVIEMAKER | Nov 23, 1992 | Substantially Equivalent |
| K923823 | 3D IMAGING | Oct 30, 1992 | Substantially Equivalent |
| K922677 | MAGNETIZATION TRANSFER CONTRAST | Sep 4, 1992 | Substantially Equivalent |
| K920254 | COILS FOR RX4000 & RX5000 MRI SYSTEMS | Jun 22, 1992 | Substantially Equivalent |
| K920835 | PRESATURATION | May 22, 1992 | Substantially Equivalent |
| K915754 | 16 BIT A/D | Mar 16, 1992 | Substantially Equivalent |