FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGITAL I.D. CAMERA
K Number: K942883
·
Decision Sep 30, 1994
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
17
Applicant Total
2
Review Days
105
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
- DIGITAL I.D. CAMERA
- K Number
- K942883
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1640
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Miles Inc., Agfa Division
- Date Received
- June 17, 1994
- Decision Date
- September 30, 1994
- 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.
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
BENNETT X-RAY ID PLUS
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Miles Inc., Agfa Division
| K Number | Device Name | ||
|---|---|---|---|
| K943602 | DI-2000 | May 12, 1995 | Substantially Equivalent |