Penile implant, Jonas

Dacomed Corp.

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

Regulatory Info

510(k) NumberK820081 ↗
Clearance Date1/24/1982
Product CodeFAE
✅No Recalls Found

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Penile

Body Region

Pelvis

MRI Conditions

Jonas malleable penile prosthesis. Contains a silver wire core. MR Conditional, but expect significant local imaging artifact. Specific SAR limits required to prevent heating — verify scan parameters with the manufacturer IFU before imaging.

Clinical Warnings

Metal-core prosthesis: image artifact + heating risk. Confirm SAR limits with IFU.

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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.