KODAK X-OMAT M20 PROCESSOR, MODEL 2
FDA 510(k) clearance K792434 · decided 1980-01-09
Clearance details
- K-number
- K792434
- Device name
- KODAK X-OMAT M20 PROCESSOR, MODEL 2
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1979-11-28
- Decision date
- 1980-01-09
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- IWZ
- Device class
- 1
- Regulation number
- 892.1840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KODAK EKTASIAN HG FILM (EHG-15) (K970154) | Eastman Kodak Company | 1997-04-04 |
| VOXGRAM (K954200) | Voxel | 1995-09-29 |
| 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE (K931604) | 3M Health Care, Ltd. | 1993-07-21 |
| 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE (K931605) | 3M Health Care, Ltd. | 1993-07-20 |
| ORWO X-RAY FILM (K920539) | Burkhart Roentgen Intl., Inc. | 1992-06-30 |
| KODAK DENTAL BARRIER PAC (K884827) | Eastman Kodak Company | 1989-01-30 |
| KODAK CFT FILM SO-141 (K862944) | Eastman Kodak Company | 1986-08-12 |
| TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (K862415) | Parexel Intl. Corp. | 1986-07-01 |
| MEDICAL X-RAY FILM (K860797) | India-America Trading Co. | 1986-03-13 |
| BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (K844554) | Belmont Equipment Corp. | 1985-02-21 |
| FR MEDICAL X-RAY FILM (K840806) | Fr Medical/Fr Chemicals | 1984-04-24 |
| POWERMAT VRP-1 X-RAY IMAGING (K840698) | Powers Chemco, Inc. | 1984-03-16 |
Recalls involving this device
No recalls on record reference this clearance.