FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K Number: K930282
·
Decision Aug 23, 1993
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
94
Review Days
214
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Basic Information
- Device Name
- AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
- K Number
- K930282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elscint, Inc.
- Date Received
- January 21, 1993
- Decision Date
- August 23, 1993
- 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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|---|---|---|---|
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| K974344 | CT SCOPE | Jun 3, 1998 | Substantially Equivalent |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP | Apr 2, 1998 | Substantially Equivalent |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 | Mar 4, 1998 | Substantially Equivalent |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | Sep 15, 1997 | Substantially Equivalent |
| K970680 | GLORY | Jun 20, 1997 | Substantially Equivalent |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 | Jun 16, 1997 | Substantially Equivalent |
| K970980 | CARDIAC SCORING FOR CT SCANNERS | May 29, 1997 | Substantially Equivalent |
| K970005 | GYREX 2T-PRESTIGE | Mar 28, 1997 | Substantially Equivalent |