FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
16 BIT A/D
K Number: K915754
·
Decision Mar 16, 1992
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
21
Review Days
84
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Basic Information
- Device Name
- 16 BIT A/D
- K Number
- K915754
- 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
- December 23, 1991
- Decision Date
- March 16, 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 |
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|---|---|---|---|
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| 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 |
| K921046 | BO POWER SUPPLY | May 28, 1992 | Substantially Equivalent |
| K920835 | PRESATURATION | May 22, 1992 | Substantially Equivalent |