FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOGRAPHIC FILM MARKETING SYSTEM
K Number: K924345
·
Decision Nov 27, 1992
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
17
Applicant Total
69
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RADIOGRAPHIC FILM MARKETING SYSTEM
- K Number
- K924345
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1640
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fischer Imaging Corp.
- Date Received
- August 27, 1992
- Decision Date
- November 27, 1992
- Product Code
- JAC
- 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 |
|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAC), ordered by most recent decision date.
DIGITAL I.D. CAMERA
FDA 510(k)
FDA Class 1
·Radiology
CT/MRI TOPOGRAPHIC MARKER
FDA 510(k)
FDA Class 1
·Radiology
FUJI EC ID CAMERA
FDA 510(k)
FDA Class 1
·Radiology
SOLSTICE XRAY RING MARKER PAD
FDA 510(k)
FDA Class 1
·Radiology
KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L
FDA 510(k)
FDA Class 1
·Radiology
ADMARK
FDA 510(k)
FDA Class 1
·Radiology
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 |