FDA product code JAC: System, X-Ray, Film Marking, Radiographic
JAC is the FDA product code for system, x-ray, film marking, radiographic. It is a Class I device, regulated under 21 CFR 892.1640 and reviewed by the Radiology panel. FDA has cleared 18 510(k) submissions under JAC, from 13 different applicants. The average 510(k) review took 87 days (median 72). FDA has posted 15 recalls for JAC devices.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Film Marking, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1640 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JAC clearance
Top JAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 6 | 1993-03-04 |
| Miles Inc., Agfa Division | 1 | 1994-09-30 |
| I.Z.I. Corp. | 1 | 1993-11-19 |
| Fujifilm Medical System U.S.A., Inc. | 1 | 1993-07-26 |
| Solstice Corp. | 1 | 1993-05-18 |
8 more applicants have JAC clearances. See the full list in Caduvo.
Most recent JAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942883 | Miles Inc., Agfa Division | DIGITAL I.D. CAMERA | 1994-09-30 | 105 |
| K930752 | I.Z.I. Corp. | CT/MRI TOPOGRAPHIC MARKER | 1993-11-19 | 280 |
| K932357 | Fujifilm Medical System U.S.A., Inc. | FUJI EC ID CAMERA | 1993-07-26 | 73 |
| K925892 | Solstice Corp. | SOLSTICE XRAY RING MARKER PAD | 1993-05-18 | 182 |
| K926404 | Eastman Kodak Company | KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L | 1993-03-04 | 73 |
Recalls for JAC devices
15 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-13.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 3 |
Frequently asked questions
What is FDA product code JAC?
JAC is the FDA product code for system, x-ray, film marking, radiographic. It is a Class I device, regulated under 21 CFR 892.1640 and reviewed by the Radiology panel.
What device class is JAC?
Class I, regulation 21 CFR 892.1640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JAC?
Across 18 cleared submissions the average was 87 days from receipt to decision (median 72).
Which companies have the most JAC clearances?
Eastman Kodak Company (6); Miles Inc., Agfa Division (1); I.Z.I. Corp. (1); Fujifilm Medical System U.S.A., Inc. (1); Solstice Corp. (1).
Have JAC devices been recalled?
Yes: 15 product recalls across 7 recall events; the most recent began 2018-06-13.
Next steps
- Run an FDA pathway report with predicate devices for product code JAC
- Run a recall and safety report across every JAC manufacturer
- Watch product code JAC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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