FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL FORTY ULTRA COMPACT VIDEO IMAGER
K Number: K940332
·
Decision Jun 8, 1994
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
19
Review Days
135
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
- MODEL FORTY ULTRA COMPACT VIDEO IMAGER
- K Number
- K940332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- International Imaging Electronics
- Date Received
- January 24, 1994
- Decision Date
- June 8, 1994
- Product Code
- LMC
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMC), ordered by most recent decision date.
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
FDA 510(k)
FDA Class 2
·Radiology
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
FDA 510(k)
FDA Class 2
·Radiology
DRYVIEW CHROMA IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CYPHER DICOM PRINT SOLUTION
FDA 510(k)
FDA Class 2
·Radiology
CARESTREAM DRYVIEW 5850 LASER IMAGER
FDA 510(k)
FDA Class 2
·Radiology
SONY UP-DF750 DIGITAL FILM IMAGER
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by International Imaging Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K972019 | PEFECT SHOT | Jul 3, 1997 | Substantially Equivalent |
| K970964 | MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM | Jun 13, 1997 | Substantially Equivalent |
| K953165 | ULTRA COMPACT VIDEO IMAGER | May 7, 1996 | Substantially Equivalent |
| K950330 | DIGITAL IMAGE ACQUISITION SYSTEM | May 7, 1996 | Substantially Equivalent |
| K934908 | FULL VIEW DIGITAL STORAGE SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| K930755 | ULTRA COMPACT VIDEO IMAGER | Sep 28, 1993 | Substantially Equivalent |
| K930765 | ULTRA COMPACT VIDEO IMAGER | Sep 13, 1993 | Substantially Equivalent |
| K921992 | MP3000 SERIES III VIDEO IMAGER | Jul 10, 1992 | Substantially Equivalent |
| K920373 | MAESTRO DIGITAL VIDEO SYSTEM | Jun 24, 1992 | Substantially Equivalent |
| K904897 | MODEL 400 ULTRA COMPACT VIDEO IMAGER | Nov 20, 1990 | Substantially Equivalent |