FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RSX 30HF
K Number: K930792
·
Decision May 19, 1993
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
69
Review Days
92
Basic Information
- Device Name
- RSX 30HF
- K Number
- K930792
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fischer Imaging Corp.
- Date Received
- February 16, 1993
- Decision Date
- May 19, 1993
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Fischer Imaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K042095 | MAMMOTEST | Oct 29, 2004 | Substantially Equivalent |
| K021113 | MAMMOPATH | Jun 13, 2002 | Substantially Equivalent |
| K981414 | LC POSITIONER | Jul 16, 1998 | Substantially Equivalent |
| K973400 | MAMMOTEST ADAPTER DRIVER | Nov 10, 1997 | Substantially Equivalent |
| K964806 | MD-1835 | Mar 4, 1997 | Substantially Equivalent |
| K961207 | EP-X BIPLANE | Aug 20, 1996 | Substantially Equivalent |
| K961022 | TANGENT VI TABLE | May 3, 1996 | Substantially Equivalent |
| K950291 | DIGITAL 625HF | Mar 23, 1995 | Substantially Equivalent |
| K945619 | ATHENA HFX | Mar 23, 1995 | Substantially Equivalent |
| K944147 | MICRO X-50 HF | Sep 16, 1994 | Substantially Equivalent |