FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTRUMENTARIUM MEGA4 HT
K Number: K923022
·
Decision Sep 22, 1992
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
1071
Applicant Total
24
Review Days
91
Basic Information
- Device Name
- INSTRUMENTARIUM MEGA4 HT
- K Number
- K923022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INSTRUMENTARIUM IMAGING, INC.
- Date Received
- June 23, 1992
- Decision Date
- September 22, 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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Other Clearances by INSTRUMENTARIUM IMAGING, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K002472 | DELTA 32 AND DELTA 32 TACT | Nov 29, 2000 | Substantially Equivalent |
| K001928 | SIGMA | Aug 2, 2000 | Substantially Equivalent |
| K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) | Jun 1, 2000 | Substantially Equivalent |
| K001171 | DELTA 16 TACT | May 12, 2000 | Substantially Equivalent |
| K973642 | ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 | Nov 21, 1997 | Substantially Equivalent |
| K955411 | DELTA 16 | Mar 21, 1996 | Substantially Equivalent |
| K925987 | INSTRUMENTARIUM MEGA4 HT | May 19, 1993 | Substantially Equivalent |
| K924921 | INSTRUMENTARIUM MEGA4 HT | May 17, 1993 | Substantially Equivalent |
| K923581 | INSTRUMENTARIUM MEGA4 HT | May 3, 1993 | Substantially Equivalent |
| K924472 | INSTRUMENTARIUM MEGA4 HT | May 3, 1993 | Substantially Equivalent |