Product Code: IZJ
FDA class 2
21 CFR 892.1620
Camera, X-Ray, Fluorographic, Cine Or Spot
Radiology
A fluorographic cine or spot X-ray camera records images from a fluoroscopic image intensifier, capturing either continuous cine sequences or individual spot images of dynamic processes such as cardiac or gastrointestinal function. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) clearance before marketing. The product code is IZJ, regulated under 21 CFR 892.1620, within the Radiology medical specialty. This device is eligible for third-party review.
510(k)s
12
FEI Numbers
0
Registration Numbers
0
Unique Applicants
11
Years Active
23
Basic Information
- Product Code
- IZJ
- Device Class
- FDA class 2
- Regulation Number
- 892.1620
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K024085 | CCD CAMERA, MODEL PKP-06000-000 | Mar 11, 2003 | Substantially Equivalent | PERKINS ELECTRONICS CO. |
| K972130 | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR | Oct 09, 1997 | Substantially Equivalent | FAIRMONT MEDICAL |
| K945580 | DSP OPTION | Jan 30, 1995 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K920793 | PHILIPS DSI SYSTEM RELEASE 3.2 | Jul 17, 1992 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K896615 | CINE CAMERA CONTROL MODEL PK2037 | Jan 04, 1990 | Substantially Equivalent | PERKINS MFG. CO. |
| K881688 | DTV-4114 FLUOROSCOPIC TELEVISION CAMERA | May 18, 1988 | Substantially Equivalent | ADAC LABORATORIES |
| K853983 | CANON X-RAY 35MM CINE CAMERA CSI-35 | Oct 16, 1985 | Substantially Equivalent | CANON U.S.A., INC. |
| K812613 | VIDICAM 200 | Dec 08, 1981 | Substantially Equivalent | DIVERSIFIED P.A. |
| K810191 | SIRCAM 103 | Feb 26, 1981 | Substantially Equivalent | SIEMENS CORP. |
| K810072 | 105MM ROLL FILM FLUOROGR. CAMERA, #105 | Feb 12, 1981 | Substantially Equivalent | SCIENTEX CORP. |
| K802132 | 105MM SPOT FILM CAMERA | Oct 23, 1980 | Substantially Equivalent | INSTRUMENTATION CAMERA, INC. |
| K792394 | SIRCAM 106 | Dec 20, 1979 | Substantially Equivalent | SIEMENS CORP. |