KODAK PORTABLE IDENTIFICATION CAMERA
FDA 510(k) clearance K890467 · decided 1989-02-16
Clearance details
- K-number
- K890467
- Device name
- KODAK PORTABLE IDENTIFICATION CAMERA
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1989-01-31
- Decision date
- 1989-02-16
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- JAC
- Device class
- 1
- Regulation number
- 892.1640
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rochester, NY, 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 |
|---|---|---|
| DIGITAL I.D. CAMERA (K942883) | Miles Inc., Agfa Division | 1994-09-30 |
| CT/MRI TOPOGRAPHIC MARKER (K930752) | I.Z.I. Corp. | 1993-11-19 |
| FUJI EC ID CAMERA (K932357) | Fujifilm Medical System U.S.A., Inc. | 1993-07-26 |
| SOLSTICE XRAY RING MARKER PAD (K925892) | Solstice Corp. | 1993-05-18 |
| ADMARK (K923533) | Planmeca USA, Inc. | 1993-03-04 |
| KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L (K926404) | Eastman Kodak Company | 1993-03-04 |
| RADIOGRAPHIC FILM MARKETING SYSTEM (K924345) | Fischer Imaging Corp. | 1992-11-27 |
| BENNETT X-RAY ID PLUS (K925332) | Bennett X-Ray Technologies | 1992-11-27 |
| KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE (K920031) | Eastman Kodak Company | 1992-02-12 |
| KODAK MIN-R IDENTIFICATION CAMERA (K915088) | Eastman Kodak Company | 1991-12-02 |
| RADIOGRAPHIC FILM MARKING SYSTEM (K913478) | Lorad Medical Systems, Inc. | 1991-10-15 |
| X-MARX (K911873) | Macbrud Corp. Medical Div. | 1991-07-19 |
Recalls involving this device
No recalls on record reference this clearance.