FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITIZER, MODEL # 3-000A-1518
K Number: K922619
·
Decision Jul 1, 1992
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
8
Review Days
33
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Basic Information
- Device Name
- DIGITIZER, MODEL # 3-000A-1518
- K Number
- K922619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lorad Medical Systems, Inc.
- Date Received
- May 29, 1992
- Decision Date
- July 1, 1992
- 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 Lorad Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921962 | LORAD DIGITAL SPOT MAMMOGRAPHY | Nov 23, 1992 | Substantially Equivalent |
| K913732 | MAMMOGRAPHIC X-RAY SYSTEM | Feb 3, 1992 | Substantially Equivalent |
| K913478 | RADIOGRAPHIC FILM MARKING SYSTEM | Oct 15, 1991 | Substantially Equivalent |
| K894935 | S-70 PORTABLE DENTAL X-RAY SYSTEM | Apr 25, 1990 | Substantially Equivalent |
| K894643 | RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT | Dec 14, 1989 | Substantially Equivalent |
| K882875 | STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY | Nov 7, 1988 | Substantially Equivalent |
| K842102 | LORAD | Jul 17, 1984 | Substantially Equivalent |