FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELTA 32 AND DELTA 32 TACT
K Number: K002472
·
Decision Nov 29, 2000
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
24
Review Days
110
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Basic Information
- Device Name
- DELTA 32 AND DELTA 32 TACT
- K Number
- K002472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentarium Imaging, Inc.
- Date Received
- August 11, 2000
- Decision Date
- November 29, 2000
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
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Other Clearances by Instrumentarium Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K923352 | INSTRUMENTARIUM MEGA4 HT | Oct 6, 1992 | Substantially Equivalent |